Download NRAC Issue #2066 September 9, 2015 11 Pages NATIONAL

NRAC Issue #2066
September 9, 2015
11 Pages
NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION
THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION
THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, DC
SUMMARY PAGE
MEDICAL DEVICES
PRODUCT
Access Thyroglobulin Assay
MANUFACTURER
Beckman Coulter Inc
PAGE 3
PRODUCT
ADVIA Centaur® Folate Ascorbic Acid/Ascorbic Acid Diluent
MANUFACTURER
Siemens Healthcare Diagnostics, Inc
PAGE 3
PRODUCT
Affirm VPIII Microbial Identification Tests
MANUFACTURER
BD Diagnostic Systems
PAGE 7
PRODUCT
CIDEX OPA Solution Instructions for Use
MANUFACTURER
Advanced Sterilization Products (ASP)
PAGE 7
PRODUCT
da Vinci Xi Surgical System P4 software with Xi Stapler
MANUFACTURER
Intuitive Surgical, Inc
PAGE 3
PRODUCT
DermaPen Pro
MANUFACTURER
Derma Pen, LLC
PAGE 3
PRODUCT
Dimension® CREA (Creatinine) and Dimension Vista® CREA (Creatinine)
MANUFACTURER
Siemens Healthcare Diagnostics, Inc
PAGE 7
PRODUCT
DigitalDiagnost
MANUFACTURER
Philips Electronics North America Corp
PAGE 9
PRODUCT
Gridlock Screw Driver Bit 2.4, 3.0, and 4.0 mm
MANUFACTURER
Trilliant Surgical Ltd
PAGE 9
PRODUCT
I-Portal® NOTC system with the OVAR research test
MANUFACTURER
Neuro Kinetics, Inc
PAGE 5
PRODUCT
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip
MANUFACTURER
C R Bard, Inc
PAGE 9
PRODUCT
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
MANUFACTURER
Mindray DS USA, Inc dba Mindray North America
1
PAGE
9
PRODUCT
Medivators Hemocor, etc
MANUFACTURER
Medtronic Perfusion Systems
PAGE 8
PRODUCT
Pressure Monitoring Kit and Set
MANUFACTURER
Edwards Lifesciences
PAGE 6
PRODUCT
Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR
MANUFACTURER
Teleflex Medical
PAGE 7
PRODUCT
SMR Shoulder/Spalla Trial Humeral Heads
MANUFACTURER
Limacorporate spa
PAGE 8
PRODUCT
Surflo IV Catheter
MANUFACTURER
Terumo Medical
PAGE 6
PRODUCT
Syngo.plaza
MANUFACTURER
Siemens Medical Solutions USA, Inc
PAGE 8
PRODUCT
Transonic Flow Probe
MANUFACTURER
Transonic Systems Inc
PAGE 4
PRODUCT
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Chemistry System Refurbished
MANUFACTURER
Ortho-Clinical Diagnostics
PAGE 4
FOOD
PRODUCT
Kraft Singles individually-wrapped slices
MANUFACTURER
Kraft Heinz Co
PAGE 9
PHARMACEUTICALS
PRODUCT
17-Hydroxyprogesterone 250 mg/mL Injectable
MANUFACTURER
Liberty Drug & Surgical
PAGE 11
PRODUCT
Bactroban (mupirocin calcium) Nasal Ointment, etc
MANUFACTURER
GlaxoSmithKline, LLC
PAGE 10
PRODUCT
Compounded Drugs Stored in Syringes
MANUFACTURER
Becton, Dickinson & Co
PAGE 11
PRODUCT
Fenoglide® (Fenofibrate) Tablets
MANUFACTURER
Valeant Pharmaceuticals North America LLC
2
PAGE
11
PRODUCT
Hospira 1% Lidocaine
MANUFACTURER
Medline Industries, Inc
PAGE 11
PRODUCT
Mucinex® Fast Max DM Max
MANUFACTURER
RB (formerly Reckitt Benckiser)
PAGE 10
PRODUCT
Topicort (desoximetasone) Topical Spray
MANUFACTURER
Taro Pharmaceuticals, Inc
PAGE 10
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack, for the quantitative
determination of thyroglobulin levels in human serum and plasma using the Access
Immunoassay Systems
RECALL NUMBER
Z-2733-2015
CODE
Catalogue number: 33860, lot#, exp date: 431990,10/31/16; 434727, 12/31/16; 430969,
8/31/16; 522896, 4/30/17; 523251, 5/31/17
MANUFACTURED & RECALLED BY
Beckman Coulter Inc, Brea, CA
QUANTITY
3035
DISTRIBUTION
Nationwide
REASON
Some may exhibit greater than 10% imprecision at concentrations <10 ng/mL
---------------------------------------------------------------------------------------------------------------- -------------------------------PRODUCT
DermaPen Pro
RECALL NUMBER
Z-2740-2015
CODE
All devices on the market
MANUFACTURED & RECALLED BY
Derma Pen, LLC, Salt Lake City, UT
QUANTITY
1,466 units
DISTRIBUTION
Nationwide and internationally
REASON
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning
letter for distributing a device without FDA clearance or approval.
---------------------------------------------------------------------------------------------------------- -------------------------------------PRODUCT
ADVIA Centaur® Folate Ascorbic Acid/Ascorbic Acid Diluent
RECALL NUMBER
Z-2739-2015
CODE
SMN 10316877, Lot Numbers: 54942, 56230, 70673
MANUFACTURED & RECALLED BY
Siemens Healthcare Diagnostics, Inc, East Walpole, MA
QUANTITY
466
DISTRIBUTION
Nationwide and internationally
REASON
Low red blood cell control recoveries and low results for red blood cell patient samples
when using the ADVIA Centaur Systems Folate assay.
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
CODE
da Vinci Xi Surgical System P4 software with Xi Stapler
Z-2734-2015
Model # IS4000, serial #s SK0036 SK0076 SK0119 SK0156 SK0198 SK0250 SK0288
SK0342 SK0395 SK0425 SK0039 SK0077 SK0120 SK0157 SK0203 SK0254 SK0289
SK0346 SK0398 SK0433 SK0046 SK0079 SK0122 SK0159 SK0206 SK0255 SK0291
3
SK0347 SK0399 SK0434 SK0047 SK0081 SK0123 SK0160 SK0209 SK0257 SK0292
SK0352 SK0400 SK0437 SK0048 SK0087 SK0127 SK0161 SK0211 SK0259 SK0293
SK0356 SK0401 SK0440 SK0049 SK0091 SK0130 SK0162 SK0212 SK0262 SK0294
SK0358 SK0402 SK0441 SK0051 SK0092 SK0134 SK0163 SK0216 SK0263 SK0296
SK0359 SK0404 SK0443 SK0054 SK0093 SK0135 SK0167 SK0225 SK0264 SK0297
SK0360 SK0406 SK0445 SK0057 SK0095 SK0137 SK0168 SK0229 SK0265 SK0298
SK0366 SK0408 SK0448 SK0058 SK0096 SK0138 SK0169 SK0231 SK0266 SK0299
SK0371 SK0409 SK0451 SK0059 SK0098 SK0139 SK0171 SK0233 SK0267 SK0301
SK0375 SK0410 SK0452 SK0061 SK0099 SK0143 SK0173 SK0234 SK0269 SK0302
SK0376 SK0412 SK0455 SK0062 SK0100 SK0144 SK0175 SK0235 SK0270 SK0304
SK0378 SK0414 SK0456 SK0066 SK0101 SK0145 SK0176 SK0236 SK0271 SK0307
SK0382 SK0415 SK0459 SK0067 SK0103 SK0146 SK0178 SK0237 SK0275 SK0309
SK0383 SK0416 SK0463 SK0069 SK0106 SK0147 SK0179 SK0238 SK0276 SK0310
SK0384 SK0417 SK0464 SK0070 SK0113 SK0148 SK0180 SK0239 SK0277 SK0311
SK0385 SK0418 SK0071 SK0114 SK0150 SK0181 SK0242 SK0284 SK0314 SK0389
SK0420 SK0072 SK0115 SK0151 SK0186 SK0243 SK0285 SK0316 SK0390 SK0422
SK0074 SK0116 SK0153 SK0193 SK0245 SK0286 SK0317 SK0394 SK0423
MANUFACTURED & RECALLED BY
Intuitive Surgical, Inc, Sunnyvale, CA
QUANTITY
198 devices
DISTRIBUTION
Nationwide
REASON
Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi
System P4 version software.
----------------------------------------------------------------------------------------------------------------------------- -----------------PRODUCT
RECALL NUMBER
CODE
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Chemistry System Refurbished
Z-2544-2015
Software Versions 2.2.1 through 2.8; Catalog #6801375 Serial Numbers: 34000119 through
34002323; Catalog #6801890 Serial Numbers: J34000133, J34000193, J34000197,
J34000212, J34000285, J34000316, J34000318, J34000337, J34000360, J34000420,
J34000451, J34000478, J34000495, J34000497, J34000529, J34000538, J34000552,
J34000557, J34000590, J34000596, J34000601, J34000631, J34000642, J34000761,
J34000799, J34000805, J34000833, J34000851, J34000893, J34000946, J34000947,
J34001006, J34001172, J34001218, J34001240, J34001243, J34001248, J34001251,
J34001274, J34001297, J34001311, J34001317, J34001345, J34001378, J34001379,
J34001389, J34001390, J34001396, J34001422, J34001472, J34001504, J34001569,
J34001572, J34001612, J34001626, J34001633, J34001668, J34001755, J34001809,
J34001840, J34001850, J34001875, J34001897
MANUFACTURED & RECALLED BY
Ortho-Clinical Diagnostics, Rochester, NY
QUANTITY
Catalog #6801375: Domestic 919; Foreign 1251; Catalog #6801890: Domestic 63, Foreign
147
DISTRIBUTION
Nationwide and internationally
REASON
Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using
Software Versions 2.2.1 through 2.8.
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
PRODUCT
1) Transonic Flow Probe, 2 mm, used to measure flow intra-operatively
Z-2720-2015
2) Transonic Flow Probe, 3 mm
Z-2721-2015
3) Transonic Flow Probe, 6 mm
Z-2722-2015
4) Transonic Flow Probe, 8 mm
Z-2723-2015
5) Transonic Flow Probe, 2 mm
4
RECALL NUMBER
PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
CODE
Z-2724-2015
6) Transonic Flow Probe, 3 mm
Z-2725-2015
7) Transonic Flow Probe, 2 mm
Z-2726-2015
8) Transonic Flow Probe, 3 mm
Z-2727-2015
9) Transonic Flow Probe, 4 mm
Z-2728-2015
1) Cat # HQC2FMC, serial #s HQC2FMC1801, HQC2FMC 1802, HQC2FMC1805,
HQC2FMC1806
2) Cat # HQC3FMC, serial #s HQC3FMC2501, HQC3FMC2502, HQC3FMC2503,
HQC3FMC2504, HQC3FMC2505, HQC3FMC2506, HQC3FMC2507, HQC3FMC2508,
HQC3FMC2509, HQC3FMC2510, HQC3FMC2511, HQC3FMC2512, HQC3FMC2513,
HQC3FMC2514, HQC3FMC2515, HQC3FMC2516, HQC3FMC2517, HQC3FMC2518,
HQC3FMC2519, HQC3FMC2520, HQC3FMC2521, HQC3FMC2522, HQC3FMC2523,
HQC3FMC2524, HQC3FMC2525, HQC3FMC2526, HQC3FMC2527, HQC3FMC2528,
HQC3FMC2529, HQC3FMC2530, HQC3FMC2531, HQC3FMC2532, HQC3FMC2533,
HQC3FMC2534, HQC3FMC2535, HQC3FMC2636
3) Cat # HQC6FMV, serial # HQC6FMV2239
4) Cat # HQC8FMV, serial #s HQC8FMV2142, HQC8FMV2143, HQC8FMV2144,
HQC8FMV2145, HQC8FMV2146
5) Cat # HQC2MP, serial #s HQC2MP2763, HQC2MP2764, HQC2MP2769,
HQC2MP2771, HQC2MP2772, HQC2MP2773
6) Cat # HQC3MP, serial #s HQC3MP4665, HQC3MP4666, HQC3MP4667,
HQC3MP4668, HQC3MP4669, HQC3MP4670
7) Cat # HQD2FMC, serial #s HQD2FMC2797, HQD2FMC2873, HQD2FMC2874,
HQD2FMC2875, HQD2FMC2876, HQD2FMC2877, HQD2FMC2878, HQD2FMC2879,
HQD2FMC2880, HQD2FMC2881, HQD2FMC2882, HQD2FMC2883, HQD2FMC2884,
HQD2FMC2885, HQD2FMC2886, HQD2FMC2888, HQD2FMC2889, HQD2FMC2890,
HQD2FMC2908
8) Cat # HQD3FMC, serial #s HQD3FMC3763, HQD3FMC3764, HQD3FMC3765,
HQD3FMC3766, HQD3FMC3767, HQD3FMC3768, HQD3FMC3769, HQD3FMC3770,
HQD3FMC3771, HQD3FMC3772, HQD3FMC3773, HQD3FMC3774, HQD3FMC3775,
HQD3FMC3776, HQD3FMC3777, HQD3FMC3778, HQD3FMC3779, HQD3FMC3780,
HQD3FMC3781, HQD3FMC3782, HQD3FMC3783, HQD3FMC3784, HQD3FMC3785,
HQD3FMC3786, HQD3FMC3787, HQD3FMC3788, HQD3FMC3789, HQD3FMC3790,
HQD3FMC3791, HQD3FMC3792, HQD3FMC3793, HQD3FMC3794, HQD3FMC3795,
HQD3FMC3796, HQD3FMC3797, HQD3FMC3798, HQD3FMC3799, HQD3FMC3800,
HQD3FMC3801, HQD3FMC3802, HQD3FMC3803, HQD3FMC3804, HQD3FMC3805,
HQD3FMC3806, HQD3FMC3807, HQD3FMC3814, HQD3FMC3815
9) Cat # HQD4FMC, serial #s HQD4FMC3504, HQD4FMC3505, HQD4FMC3506,
HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511,
HQD4FMC3512, HQD4FMC3513, HQD4FMC3514, HQD4FMC3515, HQD4FMC3516,
HQD4FMC3517, HQD4FMC3518, HQD4FMC3519, HQD4FMC3520
MANUFACTURED & RECALLED BY
Transonic Systems Inc, Ithaca, NY
QUANTITY
1) 4 units, 2) 36 units, 3) 1 unit, 4) 5 units, 5) 6 units, 6) 6 units, 7) 8 units, 8) 35 units, 9) 15
units
DISTRIBUTION
Nationwide
REASON
Software defect; programming errors in the probes EPROM. Transonic received several
complaints from users indicating that when the flow probe is connected to a flow meter the
meter reads "Used Probe" or "Irrelevant Use Number".
------------------------------------------------------------------------------------------------ -----------------------------------------------PRODUCT
I-Portal® NOTC system with the OVAR research test
5
RECALL NUMBER
CODE
Z-2730-2015
Models I-Portal NOTC-O, NOTC-C, S/N 890739, S/N 900140, S/N 900133, S/N 900114,
S/N 900172, S/N 900136, S/N 900162, S/N 900134, S/N 900137, S/N 900147, S/N 890739,
S/N 900140, S/N 900169, S/N 890738, S/N 900133, S/N 900118, S/N 900127, S/N 900138,
S/N 900163, S/N 890742, S/N 890773, S/N 900155, S/N 900150, S/N 900158, S/N 900125,
S/N 900123, S/N 900108, S/N 900114, S/N 900160, S/N 900168, S/N 900102, S/N 900130,
S/N 900131, S/N 900128, S/N 900144, S/N 890741, S/N 890726, S/N 890736, S/N 900145,
S/N 900111, S/N 900119
MANUFACTURED & RECALLED BY
Neuro Kinetics, Inc, Pittsburgh, PA
QUANTITY
45
DISTRIBUTION
Nationwide
REASON
The devices that included the OVAR research test were not cleared for marketing and mTBI
research package was sold with the incorrect investigational label.
----------------------------------------------------------------------------------------------- ------------------------------------------------PRODUCT
RECALL NUMBER
CODE
Surflo IV Catheter
To be determined
Item number: 3SR-OX2225CA, Lots: RF2727, RH1427, RK0427, RG0227, RH2127,
RK1127, RG2027, RH2827, RK1827, RG2327, RH3127, RK2527; Item number: 3SROX2419CA, Lots: RF2727, RH1427, RL2227, RG0927, RL0227, RG1627, RL0827,
RH0727, RL1527
MANUFACTURED & RECALLED BY
Terumo Medical, Somerset, NJ
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
Catheter may have damage, which could result in breakage of the catheter tubing during use.
----------------------------------------------------------------------------------------------------------------------------- ------------------PRODUCT
RECALL NUMBER
CODE
Pressure Monitoring Kit and Set
To be determined
Model number: PX2X3, Lots: 59987950, 60008882, 60043561; Model: PX3X3272, Lots:
59994227, 60025936; Model: PX3X3AN, Lots: 60008883, 60030889; Model: PXAK2066,
Lots: 60025499; Model: PXAVMP3, Lots: 60036757; Model: PXMK1970, Lots: 60001398;
Model: PXMK2043, Lots: 59994210, 60001412, 60020166, 60030868; Model: PXMK2144,
Lots: 60019038; Model: PXMK2217, Lots: 59994267, 60020235, 60030969; Model:
PXVK0458, Lots: 59983333; Model: PXVK1079, Lots: 59994195, 60020153; Model:
PXVMP2X31, Lots: 59998630, 59999004, 59999006; Model: PXVMP3X31, Lots:
59994223, 60049581; Model: PXVMP3X32, Lots: 60025874; Model: T001746A, Lot:
60036771; Model: T001759A, Lot: 59976102, 60014134, 60020177, 60049570; Model:
T330V11A, Lot: 60014160; Model: T333F00A, Lot: 59987991, 60001468, 60022033;
Model: T334041A, Lot: 60008925, 60049612; Model: T336547B, Lot: 60008919; Model:
T337305B, Lot: 59987992, 60001473; Model: T391314A, Lot: 60020222; Model:
T391T01A, Lot: 60014163; Model: T395606B, Lot: 60022034, 60025971; Model:
T430140A, Lot: 60014177; Model: T430609A, Lot: 60001486, 60043616; Model:
T431305A, Lot: 60008942, 60059909; Model: T440B20B, Lot: 59994257, 60030953;
Model: T440B21A, Lot: 59976182, 60025987; Model: T440B26B, Lot: 60030938,
60049616; Model: T443422A, Lot: 60020223, 60036750; Model: T449103B, Lot:
60008929, 60043599; Model: T450544A, Lot: 60030944; Model: T494C00B, Lot:
60001415, 60020168, 60043543; Model: T530116B, Lot: 60008937, 60022035
MANUFACTURED & RECALLED BY
Edwards Lifesciences, Irvine, CA
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
A restriction of the flow of IV fluid would result in either an inability to prime the system
before use or difficulty in flushing the line after a blood draw.
6
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
CODE
Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR
To be determined
Product code: 502501, Batch: 12EE20, 12FE26, 12GE27, 12IE37, 12GE30, 13AG21,
12LG29, 12IE36, 12IE39, 13DG06, 12JE41, 12KE48, 13BG26, 13BG36, 13DG24,
14FG03, 14GG01, 14GG03, 14HE32, 14HE34, 14IE36, 14KG11, 14JG05, 14JE43,
14KG27, 14LG06, 15BG05, 15AG34, 15AG28, 15CG24, 15DE18, 15DG38, 15EG08;
Product code: 503700-000060, Batch: 13IG21, 13LG06, 14AG04, 14FG06, 14GG01,
14LG06, 15AG28, 15CG24, 15DG38
MANUFACTURED & RECALLED BY
Teleflex Medical, Research Triangle Park, NC
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
Reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
----------------------------------------------------------------------------------------------------------------------------- ------------------PRODUCT
RECALL NUMBER
CODE
Affirm VPIII Microbial Identification Tests
To be determined
Catalog number 446257, Lot numbers: 5148857, 5173648, 5141655, 5156873; Catalog
number: 446252, Lot numbers: 5126980, 5135673, 5138774, 5140625, 5142767, 5153674,
5153675
MANUFACTURED & RECALLED BY
BD Diagnostic Systems, Sparks, MD
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
Due to blue speckles or fibers on the beads and cards.
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
Dimension® CREA (Creatinine) and Dimension Vista® CREA (Creatinine)
RECALL NUMBER
Z-2741-2015
CODE
Dimension CREA Lot Numbers:
DB5195
EA5233
FA5275
EA5315
GA5342
FA5352
BA6026
EB6047
GA6097
BA6112
FA5211
DA5258
BA5293
EA5316
FA5351
FA6006
BA6027
GB6076
BA6111
FB6139
Dimension Vista CREA Lot Numbers:
14177BB
14234BH
14280BA
14321AC
15012AA
15054AB
15091BA
15125BA
14212BD
14261BC
14301BB
14346AC
15042BA
15076BA
15125BB
15141AA
MANUFACTURED & RECALLED BY
Siemens Healthcare Diagnostics, Inc, Newark, DE
QUANTITY
Total number: Dimension Vista - 32,165; Dimension - 238,634
DISTRIBUTION
Nationwide and internationally
REASON
Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce
falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration
of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
CIDEX OPA Solution Instructions for Use
RECALL NUMBER
Safety notice
CODE
P/N 20390
MANUFACTURED & RECALLED BY
Advanced Sterilization Products (ASP), Irvine, CA
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
To remind customers of the importance of reading the warnings and following the rinsing
instructions of the Instructions for Use.
-----------------------------------------------------------------------------------------------------------------------------------------------
7
PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
CODE
1) Medivators Hemocor
Z-2735-2015
2) Perfusion Tubing Packs (with potentially affected Hemoconentrators)
Z-2736-2015
1) Model #: HPH700, HPH-1400TS, HPH-1000TS; Lots: 759625A, 759884A, 759491A,
762355A; 2) Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3,
HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2,
M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4,
M650123A, HY8R55R, TL7M46R7, M971406C, M450013B, 7U65R2, M394415A,
M450013B; Lots: 209050007, 209087876, 209107465, 209135076, 209162502, 209195930,
209241496, 209241613, 209270018, 209270092, 209297994, 209298091, 209298094,
209310403, 209326025, 209373545, 209388464, 209396017, 209401269, 209401312,
209415313, 209431890, 209464644, 209512240, 209556873, 209621268, 209644548,
209653827
MANUFACTURED & RECALLED BY
Medtronic Perfusion Systems, Brooklyn Park, MN
QUANTITY
1306
DISTRIBUTION
AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MO, MS, NJ, NY, OH, PA, TN, TX, UT,
WI
REASON
Medivators has recalled a subset of their Hemocor High Performance Hemoconcentrators,
due to low ultrafiltration performance that is below product specification.
----------------------------------------------------------------------------------------------------------------------------- ------------------PRODUCT
1) SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, SMR Shoulder/Spalla Trial
Humeral Head diameter .44 mm, SMR Shoulder/Spalla Trial Humeral Head diameter .46
mm
RECALL NUMBER
Z-2539-2015
PRODUCT
2) SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, SMR Shoulder/Spalla Trial
Heads ECC .8 mm Adaptor
RECALL NUMBER
Z-2540-2015
CODE
1) REF 9013.22.425, REF 9013.22.445, REF 9013.22.465; Lot Numbers: 14AA234,
14AA235, 14AA233; 2) REF 9013.30.021, REF 9013.30.031; Lot Numbers: 14AA146,
14AA153
MANUFACTURED & RECALLED BY
Limacorporate spa, San Daniele Del Friuli, Italy
QUANTITY
1) 110 units, 2) 93 units
DISTRIBUTION
AL, CA, CO, FL, KS, LA, MI, MN, MO, MT, NC, NV, NY, OH, TX, WA
REASON
The dimensions of the mating features of the recalled products are out of specification
causing the device to be difficult to assemble.
--------------------------------------------------------------------------------------------------------------------------------- --------------PRODUCT
Syngo.plaza; picture archiving and communications system
RECALL NUMBER
Z-2719-2015
CODE
Model Number: 10592457; Serial numbers
100544
200308
200313
200318
200323
100138
100198
100499
200309
200314
200319
200324
100174
100181
100600
200310
200315
200320
100146
100491
200251
100571
200311
200316
200321
200277
100492
200252
100263
200312
200317
200322
100177
100596
100301
MANUFACTURED & RECALLED BY
Siemens Medical Solutions USA, Inc, Malvern, PA
QUANTITY
37
DISTRIBUTION
CA, FL, KS, MA, MD, MN, MO, NY, OR, PA, WA, WI
REASON
Potential issue leading to data loss and patient data mix-up.
100302
100539
------------------------------------------------------------------------------------------------------------------------------------ ------------
8
PRODUCT
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip,
packaged in film-to-film pouches and packaged 30 per box.
RECALL NUMBER
Z-2732-2015
CODE
Product Code 50614, lot # 53621456
MANUFACTURED & RECALLED BY
C R Bard, Inc, Covington, GA
QUANTITY
8,970 each
DISTRIBUTION
CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, WA
REASON
Potential breach of the sterile barrier packaging.
6119.
----------------------------------------------------------------------------------------------------------------------------- ------------------PRODUCT
DigitalDiagnost
RECALL NUMBER
Z-2383-2015
CODE
Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage
MANUFACTURED & RECALLED BY
Philips Electronics North America Corp, Andover, MA
QUANTITY
62
DISTRIBUTION
AZ, MN, WA, WY, OH
REASON
The system is designed to emit a beep upon termination of an exposure. However, if the
system has been powered on for over 12 hours, the system will no longer emit this signal
due to a defect in the Microsoft Windows 7 operating system.
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
CODE
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
Z-2737-2015
Lot #14A18, PN: 6800F-PA00001, Serial Numbers: DU- 46002583, DU-46002587, DU46002588, DU-46002589, DU-46002592, DU-46002594, DU-46002595, DU-46002596,
DU-46002599, DU-46002600, DU-46002601, DU-46002605 and DU-46002606
MANUFACTURED & RECALLED BY
Mindray DS USA, Inc dba Mindray North America, Mahwah, NJ
QUANTITY
13 units
DISTRIBUTION
CT, IA, KY, MS, PA, UT, WA
REASON
Mindray has identified an issue where the DPM 7 Monitor may display a black screen.
------------------------------------------------------------------------------------------------------------------------- ----------------------PRODUCT
Gridlock Screw Driver Bit 2.4, 3.0, and 4.0 mm
RECALL NUMBER
Z-2738-2015
CODE
Model Number 310-30-003, Lot Number TSL002605
MANUFACTURED & RECALLED BY
Trilliant Surgical Ltd, Houston, TX
QUANTITY
108 units
DISTRIBUTION
AR, AZ, CA, FL, GA, IA, IL, IN, MN, MO, NJ, NY, OH, SD, SC, TX, VA, WI
REASON
Gridlock screwdriver bits for the Gridlock Plating System were identified to be out of
specification and have the potential for shallow engagement between the driver and the
screw, resulting in an increased likelihood of stripping screw heads intra-operatively.
----------------------------------------------------------------------------------------------------------------------------- ------------------PRODUCT
RECALL NUMBER
CODE
Kraft Singles individually-wrapped slices
Update to prior notice
Kraft Singles with manufacturing codes S54 and S55. Best When Used By Date: 4 lb
American – 13 DEC 15 through 18 FEB 16, 3 lb American (three – 1 lb packages) – 14
DEC 15 through 18 FEB 16, 3 lb White American – 12 JAN 16, 4 lb White American – 12
DEC 15 through 13 FEB 16, 1 lb – NA, 1 lb White American – NA, 3 lb American (72
individually-wrapped Singles in cardboard carton) – 09 DEC 15 through 19 FEB 16, 3 lb
Deli Deluxe American – 21 JAN 16 through 02 MAR 16
9
MANUFACTURED & RECALLED BY
Kraft Heinz Co, Northfield, IL
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
This is an update to a recall posted on 8/3/2015 to include additional varieties. Due to the
possibility that a thin strip of the individual packaging film may remain adhered to the slice
after the wrapper has been removed.
----------------------------------------------------------------------------------------------------------------------------- ------------------PRODUCT
Mucinex® Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough
Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+
RECALL NUMBER
D-1369-2015
CODE
NDC 63824-019-66; lot numbers AA189, MDM0036, MDM0039, MDM0042, MDM0043,
MDM0044, MDM0045, MDM0046, MDM0047, MDM0048, MDM0049, MDM0050,
MDM0052, MDM0053
MANUFACTURED & RECALLED BY
RB (formerly Reckitt Benckiser), Parsippany, NY
QUANTITY
416,220 Bottles
DISTRIBUTION
Nationwide
REASON
This is an update to recall numbers D-1363-2015 to D-1368-2015 posted on 4/22/2015 to
include an additional product. The over-the-counter medications, which correctly label the
product on the front of the bottle and list all active ingredients, may not have the correct
corresponding drug facts label on the back.
----------------------------------------------------------------------------------------------------------------------------- -----------------PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
PRODUCT
RECALL NUMBER
CODE
1) Bactroban (mupirocin calcium) Nasal Ointment, 2%, 1g tube, Rx only
D-1359-2015
2) Bactroban Ointment (mupirocin calcium), 2%, 22g tube, Rx only
D-1360-2015
3) Bactroban Cream (mupirocin calcium), 2%, a) 15g tube, b) 30g tube, Rx only
D-1361-2015
4) Mupirocin Calcium Cream, 2%, a) 15g tube, b) 30g tube, Rx only
D-1362-2015
Lot numbers: 1) NDC 0029-1526-11; C704202, C706532, C713177, C716567, C720097,
C720098; 2) NDC 0029-1525-44; C698039; 3) a) NDC 0029-1527-22; C695549; b) NDC
0029-1527-25; C707836, C718209; 4) a) NDC 66993-942-15; b) NDC 66993-942-31; a &
b) C690076, C693373, C701378, C701376, C704164, C713687, C719467, C718203,
C723641, C683884, C697653, C710477
MANUFACTURED & RECALLED BY
GlaxoSmithKline, LLC, Zebulon, NC
QUANTITY
1) 88,489; 2) 19,520; 3) a) 28,480; b) 12,234; 4) a) 166,070; b) 112,720 tubes
DISTRIBUTION
Nationwide
REASON
Penicillin Cross Contamination and Presence of Foreign Substance. Product was
contaminated with penicillin and foreign substances during manufacturing process.
---------------------------------------------------------------------------------------------------------------------------------- -------------PRODUCT
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only
RECALL NUMBER
D-1370-2015
CODE
NDC 51672-5281-7, lot numbers C4177-14965, C4178-14965
MANUFACTURED & RECALLED BY
Taro Pharmaceuticals, Inc, Brampton, CA
QUANTITY
16,320 Bottles
DISTRIBUTION
Nationwide
REASON
Failed Impurities/Degradation Specifications: out of specification results for impurities
testing was obtained at the 6 and 9 month time points.
----------------------------------------------------------------------------------------------------------------------------- -------------------
10
PRODUCT
17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only
RECALL NUMBER
D-1388-2015
CODE
Lot number 05112015@7
MANUFACTURED & RECALLED BY
Liberty Drug & Surgical, Chatham, NJ
QUANTITY
85 vials
DISTRIBUTION
NJ, NY
REASON
Lack of Assurance of Sterility: process deficiencies were observed in the sterile ophthalmic
and injectable products that could have compromised the sterility of the product.
----------------------------------------------------------------------------------------------------------------------------- ------------------PRODUCT
Compounded Drugs Stored in Syringes; 1 mL, 10 mL, 20 mL, 30 mL, and oral syringes
RECALL NUMBER
Update to prior notice
CODE
All lots
MANUFACTURED & RECALLED BY
Becton, Dickinson & Co, Franklin Lakes, NJ
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
This is an update to a safety notice posted on 8/19/2015 to include additional syringe sizes
and oral syringes. Drugs stored in these syringes may lose potency over a period of time due
to a possible interaction with the rubber stopper in the syringe.
----------------------------------------------------------------------------------------------------------------------------- -----------------PRODUCT
Fenoglide® (Fenofibrate) Tablets, 120 mg/90 ct bottle
RECALL NUMBER
To be determined
CODE
NDC 68012-495-90, lot number 1300939
MANUFACTURED & RECALLED BY
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
Stability failure discovered during annual stability program for the product (24 month
interval).
----------------------------------------------------------------------------------------------------------------------------- ------------------PRODUCT
RECALL NUMBER
CODE
Hospira 1% Lidocaine
To be determined
Lot numbers: DYNJ35298F – 15ED1175, DYNJRA0142 – 15ED1421, PAIN0273D –
15ED0977
MANUFACTURED BY Medline Industries, Inc, Mundelein, IL
RECALLED BY
Cardinal Health, McGaw Park, IL
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
This is a sub-recall due to a Hospira 1% Lidocaine recall. Due to visible, partially embedded
particulate within a single-dose glass teartop vial, identified as iron oxide.
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11