The Recall Desk
ModerateFDA (Devices)·Z-1805-2022·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall with no reported illnesses, injuries, or deaths. The agency explicitly states the affected devices are not likely to cause adverse health consequences. The recall is precautionary in nature due to potential product effectiveness degradation from temperature exposure.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling certain calcium alginate wound dressing products. Between June and August 2021, the manufacturer's facility experienced temperature excursions that may have impacted the products' effectiveness. The recall affects all dressings distributed to customers between June 1, 2021, and September 30, 2021.

The recalled products include multiple sizes and formats of calcium alginate sheets (2"x2", 4"x4.75", 4"x8"), rope (3/4"x12"), and skin fold management strips (10"x144"). These products were distributed nationwide.

The FDA has determined that the affected devices are not likely to cause adverse health consequences. No illnesses or injuries related to this recall have been reported. If you have questions about whether your dressings may be affected, contact your healthcare provider or McKesson Medical-Surgical.

The recalled product

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
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Wound Dressings
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • 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
  • 00612479193895 EA. i. 00612479193932
  • 00612479193949 CS
  • 00612479193925 EA. j. unknown

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 23 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 23 products in this recall →

Related recalls

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

See all →

Same hazard · reduced effectiveness

See all →