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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device

Mckesson Medical-Surgical Inc. Corporate Office: 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 e

Agency Publication Date: September 26, 2022
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Affected Products

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.

GTIN: 00732224109824; 50732224109829; 10732224109821

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

unavailable

Product: 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158

GTIN: 05060077233539 EA; 05060077233546 CA; 05060077233553 CS

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

not available

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 SOLUTIONS McKesson ADHESIVE, LIQUIBAND TISSUE FLOW SM TIP 0.5ML (12/BX 6BX/CS). Catalog #122-LFC

a. UDI-DI :10612479232256; 40612479232271; 20612479232260. Lot codes distributed between July and September 2021. b. GTIN: 10612479208183; 20612479195978; 40612479195989. c. GTIN: 20612479185863; 10612479208206; 40612479185874; 20612479185863

Lot Numbers:
codes
Product: DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E

GTIN: 00714196391346; 01714196300019; 00714196300010

Product: DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245

GTIN: 00714196245076 (EA); 10714196245073 (CS)

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

GTIN: a. 00732224720074; 50732224720079; 10732224720071. b. 00732224720081; 50732224720086; 10732224720088.

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.

GTIN: a. 00732224710174; 10732224710171. b. 00732224710433; 10732224710430.

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 Biological Indicator Pack Steam Model Number: S3069. d. STERIS CORP Celerity Celerity Sterilization Biological Indicator Vial Vaporized Hydrogen Peroxide Model Number:LCB044. e. STERIS CORP Celerity Celerity 20 Steril

GTIN: a. 00724995161569; 10724995161566. b. 00724995084653; 10724995084650. c. 00724995023867; 10724995023864. d. 00724995154233; 10724995154230. e. 00724995161552; 10724995161559. f. 00724995002558.

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.

GTIN: a. 00707387508296; 00707387457037; 50707387508291; 30707387508297; 30707387457038. b. 50707387788006; 30707387788002; 00707387788001.

Product: Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.

GTIN: 20845854053178; 30845854053175 BX; 00845854053174 EA.

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 Dressing DermaCol/Ag 2 X 2 Inch Square Sterile Model Number: 00502E

GTIN: a. 01714196303447; 00714196391322; 00714196303448. b. 00714196391421; 01714196502222; 00714196502223

Product: MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.

GTIN: 00884450023358; 10884450023355; 20884450023352

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

not available

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. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 5/8"X50YDS Catalog # GL-241. e. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 11/2"X50YDS Catalog # GL-243

GTIN: a. 809958001097. b. 809958001103. c. 00809958001127. d. 00809958001141. e. 00809958001165

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 4 X 5 Inch Rectangle Sterile Model Number: DUP88545

GTIN: a. 10381780491781 EA; 30381780491785 CS. b. 10381780491675 EA; 30381780491679 CS

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.

GTIN: a. 00815212020766. b. unknown

Product: Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140

Unknown

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 1"X5YDS STR LF (12/CS) MGM61 Catalog #61-59320. d. DERMA SCIENCES, INC. MediHoney DRESSING, MEDIHONEY GEL STR TU0.5OZ (10/BX 4BX/CS) MGM61 Catalog #DUP31805. e. DERMA SCIENCES, INC DuPad PAD, ABD STR 8X10 (25/BX 8BX/CS)

GTIN: a. 10612479136066, 40612479136074. b. 10612479136080, 40612479136098. c. 10612479136103; 40612479136111. d. 10381780486978, 30381780486972. e. 00809958081907, 00809958081914. f. 30381780491778, 10381780491774

Product: a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454

not available

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 ALGINATE AGSHEET 4"X4.75" (10/BX) Catalog #3558. d. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X8" (5/BX 10 Catalog #3559. e. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGR

GTIN: a. 00612479193901; 00612479193918 CS; 00612479193895 EA. b. 00612479193710; 00612479193727; 00612479193734 Case. c. 00612479193741; 00612479193765; 00612479193758. d. 00612479193789; 00612479193796 CS; 00612479193772 EA e. 00612479193802; 00612479193819; 00612479193826. f. 00612479193840; 00612479193857 CS; 00612479193833 EA. g. 00612479193871; 00612479193888 CS; 00612479193864 EA. h. 00612479193901; 00612479193918 CS; 00612479193895 EA. i. 00612479193932; 00612479193949 CS; 00612479193925 EA. j. unknown

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 DRESSING, WOUND GELLING FIBERHI-ABSRB AG 2X2 (10/BX 10BX/CS Catalog # 177200

GTIN: a. 00612479243545. b. 00612479253049; 00612479253056 BX; 00612479253063 CS; c. 00612479253025; 00612479253032; 00612479253018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90731
Status: Active
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Manufactured In: United States
Units Affected: 23 products (375; a. 46.9 bx b. 75.1 bx c. 13.4 bx; 25; a. 60 b. 1 box; 1 case; a. 1 box, b. 19 cases.; a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1; a. 12 bags, b. 4 bags; 9 boxes; a. 12 b. 60; 109; a. 59 b. 63; a. 17 b. 7 c. 1 d. 2 e. 5; a. 6 bx b. 308 cs.; a. 2 bx b. 3 bx; 13; a. 56.083 b. 472 btl c. 103 btl d. 133.5 bx e. 127.6 bx f. 14 bx; a. 34 b. 68; a. 131.2 boxes b. 85.7 c. 51.2 d. 92 e. 4 f. 56 g. 644.7 h. 131.2 i. 222 j. 1; a. .03bx b. 204bx c. 34bx; 16.9 ct; a. 163 bx b. 2.8 cs; a. 5 cts b. 11 cs c. 161 bx)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.