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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 precautionary recall for storage temperature exposure with no reported illnesses or injuries. The FDA explicitly states this temperature deviation is not likely to cause adverse health consequences, meeting the rubric criterion for low-risk precautionary recalls.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Advanced Medical Solutions McKesson wound dressing products in various sizes, including 4"x4.75", 4"x4", and 2"x2" gelling fiber dressings with catalog numbers 87400, 177400, and 177200. These products were distributed nationwide.
The recall is due to temperature excursions that occurred from June through August 2021 before the products were delivered. All products received between June 1, 2021 and September 30, 2021 may have been exposed to higher temperatures, which could have reduced their effectiveness.
According to the FDA, this specific temperature deviation is not likely to cause adverse health consequences. Healthcare facilities and distributors with affected products should contact McKesson Medical-Surgical Inc. for return or replacement instructions.
The recalled product
- 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…
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
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 (6)
- GTIN: a. 00612479243545. b. 00612479253049
- 00612479253056 BX
- 00612479253063 CS
- c. 00612479253025
- 00612479253032
- 00612479253018
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.
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