The Recall Desk

Archive

March 2016 recalls

772 recalls were announced in March 2016.

What the numbers show

Critical
29
Severe
169
High
353
Moderate
197
Low
24

Of the 772 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

Which agencies issued them

201–300 of 772

  • ModerateFDA (Devices)·Z-1135-2016·2016-03-23

    Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,777 sterile interlocking intramedullary screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555 INTERLOCKING IM SCREW LG 225305055 INTERLOCKING IM SCREW LG 225305555 IN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1102-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 154 sterile bone fixation screws distributed nationwide due to insufficient sealer calibration data.

    Product
    Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CRUCI 47482003403 2.0 X 34 CORT SCREW CRUCI 47482003603 2.0 X 36 CORT SCREW CRUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1171-2016·2016-03-23

    Sekisui Diagnostics Recalls Acetaminophen Assay Kits Due to Crystal Formation

    Sekisui Diagnostics is recalling 14,407 Acetaminophen L3K Assay kits because crystal formation in the reagent can cause samples to under-recover.

    Product
    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosi
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1122-2016·2016-03-23

    Zimmer Manufacturing Recalls Distal Femoral Bone Fixation Appliances

    Zimmer Manufacturing B.V. is recalling 37 sterile distal femoral bone fixation appliances due to insufficient sealer calibration data.

    Product
    Product 24 consists of all product under product code: HRS and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1166-2016·2016-03-23

    Zimmer Versys Hip Implant Recall Due to Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 1,220 units of Versus hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X 78710156
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1155-2016·2016-03-23

    Zimmer Manufacturing Recalls Pressfit Femoral Stems Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling sterile pressfit femoral stems used in hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1107-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Orthopedic Fixation Devices Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific sterile orthopedic fixation devices due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2016·2016-03-23

    Zimmer NexGen All-Poly Patella Components Recalled for Calibration Issues

    Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella and related knee arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Arthroplasty Components Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific hip arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1186-2016·2016-03-23

    Sorin Recalls Stockert Heater-Cooler 3T Units for Instruction Manual Updates

    Sorin Group USA is recalling 1,125 Stockert Heater-Cooler 3T units to update instruction manuals with water quality enhancements.

    Product
    Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1096-2016·2016-03-23

    Collagen Matrix Recalls NuOSS Cancellous Dental Product Due to Size Error

    Collagen Matrix Inc is recalling 171 units of NuOSS Cancellous dental product shipped to Massachusetts because some units may have the incorrect size.

    Product
    NuOSS Cancellous Intended for use in dental surgery.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1144-2016·2016-03-23

    Zimmer Manufacturing Recalls Mini Magna-FX Cann Screws Due to Calibration Data Issues

    Zimmer Manufacturing B.V. is recalling 3,190 units of Mini Magna-FX Cann Screws because of insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2016·2016-03-23

    Zimmer Manufacturing Recalls Bipolar Hip Liners Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 8,773 units of bipolar liners and shells for hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1106-2016·2016-03-23

    Zimmer Manufacturing Recalls 3.5mm Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 99 units of 3.5mm cortical screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT. SCREW 14MM LN 47483501601 3.5MM CORT. SCREW 16MM LN 47483501801 3.5MM CORT. SCREW 18MM LN 47483503601 3.5MM CORT. SCREW 36MM LN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1105-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 109 sterile 3.5mm cortical screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X 16MM 47234806535 3.5MM CORT SCR X 65MM 47234807035 3.5MM CORT SCR X 70MM 47234807535 3.5MM CORT SCR X 75MM 47234808035 3.5MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0747-2016·2016-03-23

    CJ Extra Fancy Long Grain Enriched Rice Recalled Due to Rodent Urine

    CJ Distribution is recalling 80 lb. bags of long grain rice after FDA inspection found rodent urine stains on pallets.

    Product
    CJ Extra Fancy Long Grain Enriched Rice. NET WT. 80 lbs (36.20 kg); nylon bag; Product of USA. Item number RG80
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1099-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling sterile 1.5 x 6 Cortical Screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1132-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Knee Patella Components Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 512 sterile I/B II Knee Domed Patella components for total knee arthroplasty due to insufficient sealer calibration data.

    Product
    Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1103-2016·2016-03-23

    Zimmer Manufacturing Recalls 2.7mm Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 60 sterile 2.7mm cortical screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.

    Product
    Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7MM CORT. SCREW 14MM, S 47482701601 2.7MM CORT. SCREW 16MM, S 47482701801 2.7MM CORT. SCREW 18M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1127-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Femoral Heads Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific sterile femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0754-2016·2016-03-23

    Faye's Texas Naturals Chili Petin Recalled for pH Testing Violations

    Faye's Texas Naturals is recalling 1,140 jars of Chili Petin Picante Caliente because pH levels were not tested as required by acidified food regulations.

    Product
    Faye's Texas Naturals Chili Petin Picante Caliente Net Wt. 16oz./452 grams in glass jars; 123 S. Courthouse Square Goliad, Texas 77963 (361)645-3136 FAYESTEXASNATURALS.NET
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1131-2016·2016-03-23

    Zimmer HGP II Acetabular Cup Recall Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 2,236 HGP II Acetabular Cup components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 6624065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0746-2016·2016-03-23

    Coca-Cola Recalls Mello Yello Cans for Undeclared Aspartame

    The Coca-Cola Company is recalling 2,522 cases of Mello Yello soda in Illinois, Indiana, and Ohio due to undeclared aspartame.

    Product
    Citrus Flavored Soda Mello Yello, 12 fl. oz. (355 ml), Canned under authority of The Coca-Cola Company, Atlanta, GA 30313, UPC 497250
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1136-2016·2016-03-23

    Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 4,752 sterile interlocking intramedullary screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKING IM SCREW LG 225303755 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225302742 INTERLOCKING IM SCREW MED 225303242 I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1167-2016·2016-03-23

    Zimmer Versys Cemented Femoral Stem Recall for Calibration Issues

    Zimmer Manufacturing B.V. is recalling 13 Versys Cemented Femoral Stems due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1158-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Intramedullary Fixation Rods Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 1,394 sterile intramedullary fixation rods and reconstruction screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 REC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1108-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling specific lots of sterile 4.5 x 26 Cortical Screws due to insufficient sealer calibration data during packaging.

    Product
    Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1123-2016·2016-03-23

    Zimmer Manufacturing Recalls Distal Femoral Components for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling specific distal femoral components used in total hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1143-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Knee Arthroplasty Bone Screws

    Zimmer Manufacturing B.V. is recalling 3,696 sterile MGII Knee Self-Tap Bone Screws due to insufficient sealer calibration data.

    Product
    Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 5110070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2016·2016-03-23

    Steris Quick Connects Recalled Due to Hysteroscope Port Mismatch

    Steris Corporation is recalling 809 Quick Connect flow units because processing instructions incorrectly list a hysteroscope model with two inlet ports when the device has only one.

    Product
    Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1130-2016·2016-03-23

    Zimmer Herbert Bone Screws Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 4,018 units of Herbert bone screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW, 3.0M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2016·2016-03-23

    Zimmer Manufacturing Recalls Compression Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 3,415 sterile compression screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47116202400 COMPRESSION SCREW 1-3/4IN 47116202100 COMPRESSION SCREW 1IN 471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1159-2016·2016-03-23

    Zimmer Precoat Tibia Plates Recalled for Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 39 sterile precoat tibia plates used in total knee arthroplasty due to insufficient sealer calibration data.

    Product
    Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0777-2016·2016-03-23

    Pharmedium Recalls Subpotent Epinephrine Injection Bags

    Pharmedium Services, LLC is recalling 6,816 bags of subpotent epinephrine injection due to discoloration and FDA-confirmed potency issues.

    Product
    NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1145-2016·2016-03-23

    Zimmer Modular Hip Cups Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling sterile modular hip cups due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 6110050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1138-2016·2016-03-23

    Zimmer Manufacturing Recalls Anti-Rotation Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling seven ITST Anti-Rotation Screws because of insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-ROTATION SCREW 225708065 ITST ANTI-ROTATION SCREW 225708565 ITST ANTI-ROTATION SCREW 225709065 ITST ANTI-ROTATION SCREW Product Us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 12 sterile bone fixation screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.

    Product
    Product 6 consists of all products under product code HWC, and same usage: Item no: 47493501001 3.5 X 10 CORT SCREW SELFT 47493501801 3.5 X 18 CORT SCREW SELFT Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1170-2016·2016-03-23

    Zimmer Zimtron Hip Arthroplasty Heads Recalled for Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 226 sterile Zimtron hip arthroplasty heads due to insufficient sealer calibration data. The affected units were packaged between August 2010 and April 2013.

    Product
    Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1183-2016·2016-03-23

    Siemens Syngo Dynamics PACS Software Recall for Measurement Package Issue

    Siemens is recalling Syngo Dynamics PACS software due to a potential issue in the VA10 measurement package. 228 units are affected nationwide.

    Product
    Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1160-2016·2016-03-23

    Zimmer Manufacturing Recalls Trilogy Acet Shell Hip Implant Components

    Zimmer Manufacturing B.V. is recalling 400 units of Trilogy Acet Shell hip implant components due to insufficient sealer calibration data.

    Product
    Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0579-2016·2016-03-23

    Restaurant Depot Recalls Swai Fillets Due to Nitrofuran Detection

    Restaurant Depot is recalling Swai Fillets because routine third-party lab testing found nitrofuran (SCA). The product was distributed in Florida.

    Product
    Swai Fillets ( 7-9 oz.) packaged in a 15 lb. blue and white box with blue and white lettering.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1119-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Appliances Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,209 units of sterile metallic bone fixation appliances due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 8114000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0773-2016·2016-03-23

    Teva Recalls Nabumetone Tablets Due to Missing Labels and Leaflets

    Teva Pharmaceuticals USA is recalling 576 bottles of Nabumetone 750 mg tablets because they lack required leaflets and approved labels.

    Product
    NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0776-2016·2016-03-23

    Medical Park Homecare Recalls Compressed Oxygen Cylinders Due to Gauge Issues

    Medical Park Homecare is recalling compressed oxygen cylinders filled using out-of-date gauges. The recall involves M6, D, and E tanks distributed in Oklahoma.

    Product
    Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1173-2016·2016-03-23

    Collagen Matrix Recalls ZCORE Porcine Xenograft Syringes for Malfunction

    Collagen Matrix Inc is recalling 200 units of ZCORE Porcine Xenograft Particulate in Syringe because the syringes were not working properly.

    Product
    ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance pres
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1177-2016·2016-03-23

    Volk Optical Recalls G-4 Gonio Lenses Due to Incorrect Lot Number

    Volk Optical Inc is recalling G-4 Small Ring Gonio Lenses because the incorrect lot number was engraved on the product.

    Product
    Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0778-2016·2016-03-23

    Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags

    Pharmedium Services, LLC is recalling specific lots of repinephrine bitartrate injection bags due to subpotency and discoloration confirmed by FDA analysis.

    Product
    NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0775-2016·2016-03-23

    Virt-Nate Prenatal Supplement Recalled for Incorrect Tablet Imprinting

    Virtus Pharmaceuticals is recalling Virt-Nate Prenatal/Postnatal supplements because some bottles contain tablets with the wrong identification code.

    Product
    Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL
    Category
    Drug
    Distribution
    1 state
  • SevereUSDA FSIS·025-2016·2016-03-22

    Freshology Recalls Chicken Salad for Undeclared Egg Allergen

    Freshology, Inc. is recalling 111 pounds of ready-to-eat chicken salad products because the included ranch dressing contains egg, an undeclared allergen.

    Product
    Freshology, Inc. Recalls Chicken Salad Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·16V165000·2016-03-22

    Weiler Trucks Recalled for Missing Reflectors on LED Marker Lights

    Weiler is recalling 368 trucks from 2002-2016 because LED marker lights lack required reflectors, reducing visibility and increasing crash risk.

    Product
    WEILER — WEILER F3, B3, B2, WT4000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V164000·2016-03-22

    Forest River Recalls 2016 Cherokee Grey Wolf Trailers for Placard Error

    Forest River is recalling 2016 Cherokee Grey Wolf recreational trailers because the Federal Placard lists incorrect tire and rim sizes, which may lead to overloading and tire blowouts.

    Product
    CHEROKEE — CHEROKEE GREY WOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V161000·2016-03-21

    Winnebago Winnie Drop Recalled for Carbon Monoxide Leak Risk

    Winnebago is recalling 2016 Winnie Drop trailers because the refrigerator compartment may not seal properly, allowing carbon monoxide to enter the cabin.

    Product
    WINNEBAGO — WINNEBAGO WINNIE DROP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16126·2016-03-21

    Panasonic Recalls Lithium-ion Laptop Battery Packs Due to Fire Hazard

    Panasonic is recalling specific lithium-ion battery packs for CF-S10 Series laptops because a manufacturing defect poses a fire risk. No injuries have been reported.

    Product
    Lithium-ion Computer Battery Packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V160000·2016-03-18

    GM Recalls 2014-2016 Chevrolet Caprice Police Pursuit for Steering Defect

    General Motors is recalling 2014-2016 Chevrolet Caprice Police Pursuit vehicles because corrosion may cause loss of electric power steering assist, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET CAPRICE POLICE PURSUIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16125·2016-03-18

    RacerMate Recalls CompuTrainer Blue Flywheels Due to Shattering Risk

    RacerMate is recalling approximately 25,000 CompuTrainer Blue Flywheels because they can shatter during use, posing a risk of injury to riders and bystanders.

    Product
    CompuTrainer Blue Flywheels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16123·2016-03-18

    IKEA Recalls Gothem Floor and Table Lamps Due to Shock Hazard

    IKEA is recalling about 30,600 Gothem floor and table lamps because damaged cables can contact the metal body, posing a shock hazard. Consumers should stop using the lamps and return them for a full refund.

    Product
    Gothem floor and table lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16E022000·2016-03-18

    ISS Recalls Evercraft Jack Stands Due to Potential Weld Defects

    International Specialty Services is recalling Evercraft jack stands sold by NAPA Auto Parts because improper welds may cause the stands to collapse, posing an injury risk.

    Product
    EQUIPMENT:MECHANICAL:INTEGRATED JACK/LEVELER/STABILIZER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E021000·2016-03-17

    Battery-Biz Recalls Cyntur Lithium Ion Jumpstarters Due to Fire Risk

    Battery-Biz is recalling Cyntur CTJSLI Lithium Ion Jumpstarters because a faulty cable design may cause overheating and fire. Owners should contact customer service for a free replacement cable.

    Product
    EQUIPMENT:ELECTRICAL recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V157000·2016-03-17

    Rosenbauer Commander Recall for Brake Pedal Piston Corrosion

    Rosenbauer is recalling 2012-2015 Commander vehicles because brake pedal pistons may corrode, making brakes difficult to activate or causing them to drag.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V158000·2016-03-17

    Jayco Recalls 2016 White Hawk Travel Trailers Due to Axle Defect

    Jayco is recalling 10 model year 2016 White Hawk travel trailers because they were built with axles rated for 3000 lbs instead of the required 3500 lbs, which may affect handling.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0733-2016·2016-03-16

    Living Tree Community Foods Recalls Organic Macadamia Nuts Due to Salmonella Risk

    Living Tree Community Foods is recalling 4 oz. pouches of Organic Macadamia Nuts due to potential Salmonella contamination. The recall affects 195 units distributed in 23 US states.

    Product
    Living Tree Community Foods Organic Macadamia Nuts, 4 oz. plastic pouch. Certified Organic
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Drugs)·D-0771-2016·2016-03-16

    Tf Supplements Recalls Rhino 7 3000 Due to Undeclared Ingredients

    Tf Supplements is recalling Rhino 7 3000 bottles because they contain undeclared desmethyl carbondenafil and dapoxetine and were marketed without an approved NDA or ANDA.

    Product
    RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1063-2016·2016-03-16

    Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

    Arrow International is recalling Percutaneous Insertion Trays because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0344-2016·2016-03-16

    Homestat Farm Organic Oats Recalled for Salmonella Typhimurium Contamination

    Homestat Farm is recalling Organic Quick Steel Cut Oats & Chia with Flax and Rye Flakes because the flax meal ingredient tested positive for Salmonella Typhimurium.

    Product
    ORGANIC HOMESTAT FARM Quick STEEL CUT OATS & CHIA with Flax and Rye Flakes NET WT 42 OZ (2 LB. 10 OZ.) INGREDIENTS:***organic milled flaxseed*** Distributed by Homestat Farm LTD 6065 Frantz Rd. Suite 206, Dublin, OH 43017 UPC 8 35882 00620 4
    Category
    Food
    Distribution
    16 states
  • CriticalFDA (Food)·F-0725-2016·2016-03-16

    Illes Food Ingredients Recalls Asiago Cheese Sauce Seasoning for Salmonella

    Illes Food Ingredients Ltd. is recalling 50 bags of Asiago Cheese Sauce Seasoning because the product tested positive for Salmonella.

    Product
    Asiago Cheese Sauce Seasoning NET CONTENTS: 44.3 POUNDS 20.1 KILOGRAMS packed in flexible bags
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0772-2016·2016-03-16

    Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients

    Tf Supplements is recalling Rhino 7 Platinum 3000 because it contains undeclared desmethyl carbondenafil and dapoxetine and was marketed without an approved NDA or ANDA.

    Product
    Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1059-2016·2016-03-16

    Arrow UltraFlex IAB Recall: Sheath Separation Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0734-2016·2016-03-16

    Living Tree Community Foods Recalls Organic Macadamia Butter for Salmonella Risk

    Living Tree Community Foods is recalling Organic Macadamia Butter due to potential Salmonella contamination. Consumers should stop using the product.

    Product
    Living Tree Community Foods Organic Macadamia Butter, 8 oz. glass jar. Certified Organic. UPC 64143200987
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Food)·F-0740-2016·2016-03-16

    R&D Technical Center Recalls Peanut Drop Coating for Listeria

    R&D Technical Center is recalling Clasen Quality Coatings NH Atlas 1M Creamy Peanut Drop after a positive Listeria monocytogenes test.

    Product
    Clasen Quality Coatings NH Atlas 1M Creamy Peanut Drop, Item # 12649, Net Wt. 50 lbs (22.68 KG)
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-1061-2016·2016-03-16

    Arrow RediGuard IAB Recall Due to Sheath Separation Risk

    Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0730-2016·2016-03-16

    Picnic Gourmet Herbed Goat Cheese Spread Recalled for Listeria

    Picnic Gourmet Spreads LLC is recalling Herbed Goat Cheese Spread after a related product tested positive for Listeria monocytogenes.

    Product
    Picnic Gourmet Spreads ( Herbed Goat Cheese Spread) 8 oz containers .12 Containers per case
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1058-2016·2016-03-16

    Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0728-2016·2016-03-16

    Picnic Gourmet Tandoori Garlic Cheese Spread Recalled for Listeria

    Picnic Gourmet Spreads LLC is recalling Tandoori Garlic Cheese Spread after Maryland health officials detected Listeria monocytogenes in a related product.

    Product
    Picnic Gourmet Spreads ( Tandoori Garlic Cheese Spread) 8 oz containers .12 Containers per case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0750-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 25 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0758-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling specific hydromorphone and bupivacaine syringes due to a lack of assurance of sterility.

    Product
    Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0745-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Morphine Sulfate and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling Morphine Sulfate and Bupivacaine syringes due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0752-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 10 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0757-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling specific syringes of Hydromorphone and Bupivacaine due to a lack of assurance of sterility.

    Product
    Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1081-2016·2016-03-16

    Stryker Position Pro Mattress Recalled for Power Cord Fire Risk

    Stryker is recalling Position Pro Mattresses because the power cord may melt, posing risks of electric shock and fire.

    Product
    Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated contro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0731-2016·2016-03-16

    Picnic Gourmet Spreads Recalls Moroccan Cilantro Cheese Spread for Listeria

    Picnic Gourmet Spreads LLC is recalling Moroccan Cilantro Cheese Spread after testing revealed the presence of Listeria monocytogenes.

    Product
    Picnic Gourmet Spreads ( Moroccan Cilantro Cheese Spread) 8 oz containers .12 Containers per case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0755-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/Clonidine HCL 450 mcg/ml syringes due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V155000·2016-03-16

    Winnebago Recalls 2015-2016 RVs for Improperly Torqued Hitch Bolts

    Winnebago is recalling certain 2015-2016 Adventurer and Itasca Suncruiser vehicles because hitch bolts were not properly torqued, which could cause the hitch to detach and increase crash risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA ADVENTURER, SUNCRUISER, COMMERCIAL VEHICLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0740-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Baclofen Syringes

    Hartley Medical Center Pharmacy is recalling specific hydromorphone and baclofen syringes due to a lack of assurance of sterility.

    Product
    Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0736-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Morphine and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling Morphine Sulfate and Bupivacaine HCL syringes due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0763-2016·2016-03-16

    Morphine Sulfate Syringes Recalled for Lack of Sterility Assurance

    Hartley Medical Center Pharmacy is recalling Morphine Sulfate 0.5 mg/ml syringes due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0760-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling specific hydromorphone and bupivacaine syringes due to a lack of assurance of sterility.

    Product
    Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Sufentanil Citrate Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Sufentanil Citrate/Clonidine/Bupivacaine syringes because the agency could not ensure the product was sterile.

    Product
    Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0764-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 0.5 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide

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