FDA (Devices) recall action 90731

Mckesson Medical-Surgical Inc. Corporate Office recalled 23 products on 2022-10-05

The FDA (Devices) publishes a recall like this one as 23 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 23 pages.

Products: 23
Announced: 2022-10-05
Critical: 0
Units: 532

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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

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.

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.

1–23 of 23

ModerateFDA (Devices)··2022-10-05
McKesson Wound Dressing Products Recalled for Temperature Exposure
McKesson wound dressing products distributed nationwide are being recalled due to exposure to elevated temperatures during storage that may have reduced their effectiveness. No adverse health consequences have been reported.
Product
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.75 (10/BX 10BX/CS Catalog #177400. c. ADVANCED MEDICAL SOLUTIONS McKesson DR
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0 states
ModerateFDA (Devices)··2022-10-05
Sterilization Roll Recalled Due to Temperature Exposure During Manufacturing
SPS Medical Supply Crosstex sterilization rolls (model SCT3) are being recalled because they were exposed to high temperatures during manufacturing facility storage before shipment. Temperature exposure may have compromised the product's sterilization effectiveness.
Product
SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.
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0 states
ModerateFDA (Devices)··2022-10-05
Saline wound flush recalled due to temperature exposure affecting effectiveness
Mckesson is recalling SafeWash Saline Wound Flush due to temperature exposure that may have reduced product effectiveness. The recall affects units distributed nationwide from June through September 2021.
Product
DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245
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0 states
ModerateFDA (Devices)··2022-10-05
Wound Dressing Units Recalled Due to Storage Temperature Excursions
KerraCel Ag wound dressing units distributed between June and September 2021 are being recalled due to facility temperature excursions that may have affected product effectiveness. The FDA states no adverse health consequences are likely.
Product
3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158
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0 states
ModerateFDA (Devices)··2022-10-05
Medical Monofilament Testing Devices Recalled for Temperature Excursion
Mckesson Medical-Surgical is recalling monofilament sensory testing devices (13 units) due to temperature excursions during June-August 2021. Heat exposure may have compromised device effectiveness.
Product
Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140
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0 states
ModerateFDA (Devices)··2022-10-05
3M and Comply Sterilization Indicators Recalled for Temperature Excursions
Sterilization indicator products from Mckesson Medical-Surgical distributed nationwide may have been exposed to higher temperatures between June and August 2021. The temperature excursions may have impacted product effectiveness in verifying sterilization processes.
Product
a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.
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0 states
ModerateFDA (Devices)··2022-10-05
STERIS Sterilization Indicators Recalled Due to Temperature Excursions
Six sterilization monitoring devices from STERIS Corporation were recalled due to temperature excursions during storage and delivery that may have compromised their effectiveness. Affected products were distributed nationwide between June and September 2021.
Product
a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biol
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0 states
ModerateFDA (Devices)··2022-10-05
Surgical Smoke Evacuation Prefilters Recalled Due to Temperature Exposure
Cooper Surgical PREFILTER, SMOKE EVAC prefilters are recalled because they were exposed to higher temperatures during storage from June through August 2021. This exposure may have reduced the product's effectiveness.
Product
Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.
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0 states
ModerateFDA (Devices)··2022-10-05
Sterilization Chemical Indicator Strips Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling SPS Medical sterilization indicator strips due to temperature excursions that may have reduced their effectiveness. Products distributed June–September 2021 are affected.
Product
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilization Steam Plus Monitor Model Number: SSI-1000.
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0 states
ModerateFDA (Devices)··2022-10-05
Dynarex Wet Wipes Recalled Due to Facility Temperature Exposure
McKesson Medical-Surgical Inc. is recalling three Dynarex wet wipe products that may have been exposed to higher temperatures at the facility before delivery, potentially reducing their effectiveness. All lots received between June and September 2021 are affected.
Product
a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 1313. b. DYNAREX DynaCare WIPE, WET FLUSHABLE ADULT 9X13" (24/PK 24PK/CS) Catalog # 1322. c. DYNAREX dynacare WIPE, WET FLUSHABLE JR 5X8" (42/BX 12BX/CS) Catalog # 1324
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0 states
ModerateFDA (Devices)··2022-10-05
Dynarex Unna Boot Dressing products recalled due to temperature storage excursion
Mckesson Medical-Surgical is recalling Dynarex Unna Boot Dressing products exposed to temperature excursions during June-August 2021. The manufacturer states the deviation is unlikely to cause health consequences, but products may have reduced effectiveness.
Product
a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454
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0 states
ModerateFDA (Devices)··2022-10-05
Surgitube Surgical Bandages Recalled for Temperature Exposure During Storage
McKesson is recalling Surgitube surgical bandages distributed between June and September 2021 that may have been exposed to elevated temperatures during storage. The FDA states the temperature exposure is unlikely to cause adverse health effects.
Product
a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d. D
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LowFDA (Devices)··2022-10-05
AquaGuard Wound Dressing Recall Due to Facility Temperature Excursions
TIDI Products AquaGuard wound dressings received June–September 2021 were exposed to elevated storage temperatures that may have impacted product effectiveness. The FDA states adverse health consequences are unlikely.
Product
a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR BARR 10X12 (5/BX) Catalog #68751510105
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0 states
ModerateFDA (Devices)··2022-10-05
Petrolatum Jelly Recalled Due to Temperature Exposure Prior to Delivery
Petrolatum jelly products are being recalled because facility temperature excursions from June through August 2021 may have reduced product effectiveness. The FDA states this specific storage deviation is not likely to cause adverse health consequences.
Product
a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145
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ModerateFDA (Devices)··2022-10-05
McKesson Absorbent Dressings Recalled Due to Temperature Storage Excursions
McKesson absorbent dressings manufactured by Derma Sciences are being recalled due to temperature excursions during storage from June to August 2021. The FDA states the affected dressings are not likely to cause adverse health consequences.
Product
Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN
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0 states
ModerateFDA (Devices)··2022-10-05
SporView Sterilization Biological Indicator Kit Recalled for Temperature Exposure
McKesson is recalling SporView Culture Set biological indicator kits (models CS-020 and CS-100) due to facility temperature excursions that may have compromised product effectiveness. Affected units were distributed nationwide between June and September 2021.
Product
a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100
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0 states
ModerateFDA (Devices)··2022-10-05
Collagen Powder Recalled Due to Temperature Exposure During Shipment
DermaCol 100 Collagen Powder was exposed to higher temperatures during storage from June to August 2021. The product's effectiveness may have been impacted, though the FDA determined no adverse health consequences are likely.
Product
DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
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0 states
ModerateFDA (Devices)··2022-10-05
Skin markers recalled due to storage temperature exposure
Mckesson Medical-Surgical Inc. recalls skin markers used in medical imaging that may have been exposed to excessive temperatures during storage prior to delivery. Affected units were received between June and September 2021.
Product
Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20.
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LowFDA (Devices)··2022-10-05
Mckesson DermaCol Collagen Dressings Recalled for Storage Temperature Excursion
Mckesson recalls DermaCol collagen dressings exposed to temperature excursions during storage (June-August 2021). FDA stated adverse health consequences are unlikely.
Product
a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamine-tetraacetic Acid (EDTA) 4 X 4 Inch 10 Count Model Number: 00303E. b. DERMARITE INDUSTRIES DermaCol Ag Silver Collagen Dress
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ModerateFDA (Devices)··2022-10-05
McKesson LiquiBand Exceed Skin Adhesive Storage Temperature Exposure Recall
McKesson is recalling LiquiBand Exceed skin adhesive products nationwide due to facility temperature excursions between June and August 2021. The FDA states the affected products are not likely to cause adverse health consequences.
Product
a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LBXS. b. Skin Adhesive McKesson LiquiBand Exceed 0.8 mL Liquid Precision and Dome Applicator Tip 2-Octyl Cyanoacrylate. Ref: 122-LBX. c. ADVANCED MEDICAL SOLU
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ModerateFDA (Devices)··2022-10-05
McKesson Calcium Alginate Wound Dressings Recalled for Temperature Exposure During Storage
McKesson Medical-Surgical is recalling multiple calcium alginate wound dressings due to facility temperature excursions that may have impacted product effectiveness. The FDA states the affected products are not likely to cause adverse health consequences.
Product
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) Catalog #3557. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINA
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0 states
ModerateFDA (Devices)··2022-10-05
StayFIX Percutaneous Catheter Fixation Device Recalled Due to Storage Temperature Exposure
MERIT MEDICAL SYSTEMS StayFIX catheter fixation devices recalled due to facility temperature excursions during storage before delivery. Approximately 109 units received between June-September 2021; manufacturer states no adverse health consequences are likely.
Product
MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.
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ModerateFDA (Devices)··2022-10-05
Wound Care Dressings Recalled Due to Temperature Exposure
Mckesson is recalling Shur-Conform and ALGICELL wound care dressings due to temperature exposure affecting product effectiveness. All affected units were distributed June through September 2021.
Product
a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042. b. INTEGRA LIFESCIENCE (WND CARE) ALGICELL Ag Silver Alginate Dressing Algicell Ag
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