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.
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: FDA Class III recall with theoretical risk to product effectiveness but no reported adverse health consequences. The source explicitly states the device is 'not likely to cause adverse health consequences,' making this a precautionary, low-risk recall.
Plain-English summary
Mckesson Medical-Surgical is recalling two INTEGRA LIFESCIENCE wound care dressing products: Shur-Conform Oil Emulsion Impregnated Dressing (3 X 8 Inch, Model 77042) and ALGICELL Ag Silver Alginate Dressing (4 X 5 Inch, Model DUP88545). The recall applies to all lots distributed nationwide that were received between June 1, 2021, and September 30, 2021.
The recall is due to temperature excursions at the manufacturing facility between June and August 2021, prior to product delivery. Exposure to elevated temperatures may have affected product effectiveness. The FDA and manufacturer have determined that this specific storage temperature deviation is not likely to cause adverse health consequences.
Patients and healthcare facilities that received these affected products should consult their healthcare provider or the manufacturer for guidance. No injuries or adverse events related to this temperature exposure have been reported.
The recalled product
- 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
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- reduced-effectiveness
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 (3)
- GTIN: a. 10381780491781 EA
- 30381780491785 CS. b. 10381780491675 EA
- 30381780491679 CS
Distribution
Distributed nationwide across the United States.
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