FDA (Devices) recall action 90336

Mckesson Medical-Surgical Inc. Corporate Office recalled 55 products on 2022-08-31

The FDA (Devices) publishes a recall like this one as 55 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 55 pages.

Products: 55
Announced: 2022-08-31
Critical: 0
Units: 1,140

Why these products were recalled

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

XXX

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 55

HighFDA (Devices)··2022-08-31
McKesson Colorectal Cancer Screening Tests Recalled Due to Temperature Exposure
McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.
Product
a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult…
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ModerateFDA (Devices)··2022-08-31
Drugs of Abuse Test Kits Recalled Due to Temperature Exposure
McKesson Medical-Surgical is recalling multiple brands of drugs of abuse test kits because temperature excursions prior to delivery may have reduced product effectiveness.
Product
Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine…
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ModerateFDA (Devices)··2022-08-31
FDA Recalls Heparin Sodium Prefilled Syringes Due to Heat Damage
Mckesson Medical-Surgical Inc. is recalling Excelsior Heparin Sodium prefilled syringes that may have been damaged by temperature excursions during manufacturing, potentially affecting their effectiveness. The recall covers lots received between June and September 2021.
Product
Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604
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0 states
ModerateFDA (Devices)··2022-08-31
IV Securement Kit Recall Due to Storage Temperature Damage
McKesson is recalling Medline Centurion IV Securement Kits that were exposed to high temperatures during storage, which may have impacted product effectiveness. No illnesses have been reported.
Product
MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3
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HighFDA (Devices)··2022-08-31
Central Venous Catheter Kits Recalled for Potential Temperature Damage
McKesson Medical-Surgical is recalling Teleflex Arrow Central Venous Catheter Kits due to temperature excursions during storage and shipment. Exposure to higher temperatures may have reduced product effectiveness.
Product
TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
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ModerateFDA (Devices)··2022-08-31
Fischer Cone Biopsy Excisor recalled for potential temperature damage
McKesson is recalling Fischer Cone Biopsy Excisor Model 900-157 units because temperature excursions during storage may have compromised product effectiveness.
Product
Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
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HighFDA (Devices)··2022-08-31
Surgical ophthalmic wicks recalled for potential effectiveness loss
McKesson Medical-Surgical Inc. is recalling Beaver-Visitec Ultracell surgical wicks due to facility temperature excursions during storage. Temperature exposure may have impacted product effectiveness, affecting units distributed nationwide between June and September 2021.
Product
BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C
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0 states
HighFDA (Devices)··2022-08-31
B. Braun Gravity Mixing Container Recalled for Temperature Exposure
B. Braun EVA Gravity Mixing Container 1000 mL units may have been exposed to higher temperatures during storage prior to delivery, potentially affecting product effectiveness. Units distributed nationwide between June and September 2021 are affected.
Product
B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363
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0 states
ModerateFDA (Devices)··2022-08-31
McKesson Medefil Normal Saline IV Flush Syringes Recalled for Temperature Exposure
McKesson is recalling Medefil Normal Saline IV Flush Syringes (Models MIS-1130 and 191-MIS-1130) due to facility temperature excursions between June and August 2021. Products received through September 30, 2021 may have impaired effectiveness from temperature exposure prior to delivery.
Product
a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130.
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HighFDA (Devices)··2022-08-31
Beckman Coulter Laboratory Reagents Recalled for Temperature-Related Effectiveness Loss
Beckman Coulter diagnostic reagents used in blood analysis systems were recalled after exposure to temperature excursions during storage and shipment. Products received between June and September 2021 may have reduced effectiveness.
Product
BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500…
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ModerateFDA (Devices)··2022-08-31
Fisher Scientific Sure-Vue Pipette Recall Due to Temperature Exposure
Mckesson Medical-Surgical is recalling Fisher Scientific Sure-Vue RPR Dispensing Pipettes due to temperature excursions during storage from June to August 2021. Exposure to higher temperatures may have impacted product effectiveness.
Product
FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015
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ModerateFDA (Devices)··2022-08-31
McKesson and Metrex Research Glutaraldehyde Disinfectants Recalled Due to Temperature Excursion
McKesson and Metrex Research are recalling glutaraldehyde disinfectants due to facility temperature excursions from June to August 2021 that may have reduced product effectiveness. Affected lots were distributed nationwide between June 1 and September 30, 2021.
Product
a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5%…
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HighFDA (Devices)··2022-08-31
Perifix LOR Syringes Recalled Due to Temperature Exposure During Storage
Mckesson recalled 415 Perifix LOR syringes (Model 332152) distributed nationwide due to temperature excursions from June to August 2021 that may have affected product effectiveness. No illnesses have been reported.
Product
Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152
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HighFDA (Devices)··2022-08-31
Morrison Medical OB Kit Recalled Due to Temperature Excursion During Storage
Mckesson is recalling Morrison Medical OB Kits because facility temperature excursions may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.
Product
MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL
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HighFDA (Devices)··2022-08-31
Medical Device Recall: Wetfield Eraser Bipolar Hemostatic due to temperature exposure
McKesson is recalling Wetfield Eraser Bipolar Hemostatic devices that were exposed to elevated facility temperatures from June to August 2021 prior to delivery. This exposure may have impacted the devices' effectiveness.
Product
Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265
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0 states
HighFDA (Devices)··2022-08-31
Medical device recall for temperature exposure during storage
McKesson Medical-Surgical is recalling multiple medical devices that experienced temperature excursions during storage and transport. Exposure to higher temperatures from June through August 2021 may have reduced product effectiveness.
Product
a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST…
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HighFDA (Devices)··2022-08-31
Mckesson Ultracell Eye Pledgets Recalled Over Temperature Exposure During Storage
Mckesson Medical-Surgical is recalling Ultracell Eye Pledgets (Model 40825) due to temperature excursions during storage and transportation between June and August 2021 that may have compromised product effectiveness. Affected units were distributed nationwide from June through September 2021.
Product
Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825
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0 states
HighFDA (Devices)··2022-08-31
Chest Drain System Atrium 2100 mL recalled due to temperature exposure
The GETINGE OCEAN Chest Drain System Atrium 2100 mL is being recalled due to facility temperature excursions from June-August 2021 that may have impacted product effectiveness. Affected units were distributed nationwide between June 1 and September 30, 2021.
Product
GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
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0 states
HighFDA (Devices)··2022-08-31
Medical disinfectant recalled due to temperature exposure during storage
McKesson is recalling CaviCide and EnviroCide disinfectants that may have been exposed to excessive temperatures during storage from June to August 2021, potentially reducing their effectiveness.
Product
a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL…
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ModerateFDA (Devices)··2022-08-31
Dynarex Lemon Glycerin Swabs recalled due to temperature exposure
Dynarex lemon glycerin swabs distributed nationwide may have reduced effectiveness due to temperature excursions prior to delivery. All lots received between June 1 and September 30, 2021 are affected.
Product
Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216
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HighFDA (Devices)··2022-08-31
BD Vacutainer Urine Collection Tubes Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling BD Vacutainer urine collection tubes and kits due to facility temperature excursions from June to August 2021 that may have compromised preservative effectiveness. All lots distributed between June 1 and September 30, 2021 are affected.
Product
a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON…
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ModerateFDA (Devices)··2022-08-31
Dynarex DynaLube Lubricating Jelly Recalled Due to Temperature Excursions
Mckesson is recalling Dynarex DynaLube lubricating jelly due to facility temperature excursions from June-August 2021 that may have degraded product effectiveness. Recall affects 17.5 boxes distributed nationwide between June-September 2021.
Product
DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250
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HighFDA (Devices)··2022-08-31
Centurion Catheter Kits Recalled Due to Temperature Exposure
Mckesson Medical-Surgical is recalling Centurion catheter kits that were exposed to higher temperatures during facility storage prior to delivery, which may have impacted product effectiveness. All units distributed nationwide between June 1 and September 30, 2021 are affected.
Product
CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L
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ModerateFDA (Devices)··2022-08-31
DisCide Ultra Surface Disinfectant Recalled Due to Temperature Exposure
McKesson Medical-Surgical's DisCide Ultra Surface Disinfectant Cleaner is being recalled because temperature excursions may have reduced product effectiveness. The recall affects all lots distributed nationwide between June and September 2021.
Product
Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal. Jug Herbal Scent NonSterile Model Number: 3565G
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HighFDA (Devices)··2022-08-31
Drug screening tablets affected by temperature exposure during storage
McKesson is recalling Alere Toxicology drug screening tablets due to temperature excursions during facility storage that may have reduced product effectiveness. Affected units were received between June and September 2021.
Product
Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875
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0 states