Recall Register

Food, drugs, devices › Mckesson Medical-Surgical Inc. Corporate Office

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

FDA enforcement event 90731 · Class III · initiated 25 May 2022 · status Ongoing

DeviceVoluntary: Firm initiated23 product recordsRichmond, VA

FDA enforcement event 90731 is a device recall by Mckesson Medical-Surgical Inc. Corporate Office of Richmond, VA, initiated 25 May 2022 and classified Class III, with 23 product records.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Mckesson Medical-Surgical Inc. Corporate Office has 15 enforcement events on this register, with a median of 3 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA.

Reason for recall

"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."

Distribution

"US Nationwide distribution."

Product records

Recall numberProductQuantityClassStatusReport date
Z-1787-2022DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245375Class IIIOngoing5 Oct 2022
Z-1788-2022a. 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…a. 46.9 bx b. 75.1 bx c. 13.4 bxClass IIIOngoing5 Oct 2022
Z-1789-2022DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E25Class IIIOngoing5 Oct 2022
Z-1790-2022a. 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-100a. 60 b. 1 boxClass IIIOngoing5 Oct 2022
Z-1791-2022SPS 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: SCT3.1 caseClass IIIOngoing5 Oct 2022
Z-1792-2022a. 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.a. 1 box, b. 19 cases.Class IIIOngoing5 Oct 2022
Z-1793-2022a. 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:…a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1Class IIIOngoing5 Oct 2022
Z-1794-2022a. 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.a. 12 bags, b. 4 bagsClass IIIOngoing5 Oct 2022
Z-1795-2022Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.9 boxesClass IIIOngoing5 Oct 2022
Z-1796-2022a. 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…a. 12 b. 60Class IIIOngoing5 Oct 2022
Z-1797-2022MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.109Class IIIOngoing5 Oct 2022
Z-1798-2022a. 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 #68751510105a. 59 b. 63Class IIIOngoing5 Oct 2022
Z-1799-2022a. 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…a. 17 b. 7 c. 1 d. 2 e. 5Class IIIOngoing5 Oct 2022
Z-1800-2022a. 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:…a. 6 bx b. 308 cs.Class IIIOngoing5 Oct 2022
Z-1801-2022Skin 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.a. 2 bx b. 3 bxClass IIIOngoing5 Oct 2022
Z-1802-2022Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM14013Class IIIOngoing5 Oct 2022
Z-1803-2022Absorbent 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…a. 56.083 b. 472 btl c. 103 btl d. 133.5 bx e. 127.6 bx f. 14 bxClass IIIOngoing5 Oct 2022
Z-1804-2022a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454a. 34 b. 68Class IIIOngoing5 Oct 2022
Z-1805-2022a. 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.…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. 1Class IIIOngoing5 Oct 2022
Z-1806-2022a. 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…a. .03bx b. 204bx c. 34bxClass IIIOngoing5 Oct 2022
Z-1807-20223M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL115816.9 ctClass IIIOngoing5 Oct 2022
Z-1808-2022a. 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 #1145a. 163 bx b. 2.8 csClass IIIOngoing5 Oct 2022
Z-1809-2022a. 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 # 1324a. 5 cts b. 11 cs c. 161 bxClass IIIOngoing5 Oct 2022

Context

4%of 2022 device events are Class III839 events that year
23product records in this eventfirm median: 3
15events on this register for the firm

Other enforcement events for Mckesson Medical-Surgical Inc. Corporate Office

InitiatedProduct (first record)TypeClassRecords
30 Jul 2025Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020DeviceClass II1
25 Apr 2025Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: DrugClass II2
24 Apr 2025ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROLDeviceClass II32
21 Apr 2025PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, DrugClass II3
17 Sep 2024Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a conDeviceClass II1
11 Sep 2024Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for andDrugClass II1
11 Sep 2024Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208DrugClass II1
23 Apr 2024Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog NumbeDeviceClass II1
7 Feb 2024Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LDrugClass II3
9 Jan 2024Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial VaginosisDeviceClass II5

All 15 events for Mckesson Medical-Surgical Inc. Corporate Office

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.