Mckesson DermaCol Collagen Dressings Recalled for Storage Temperature Excursion
Mckesson recalls DermaCol collagen dressings exposed to temperature excursions during storage (June-August 2021). FDA stated adverse health consequences are unlikely.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a Class III medical device recall with no reported illnesses or injuries. The FDA explicitly states the devices are 'not likely to cause adverse health consequences.' The hazard involves potential loss of product effectiveness due to storage temperature deviation, not a direct safety risk.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling certain DermaCol collagen wound dressings: the DermaCol Collagen Dressing Without Border (Model 00303E, 4x4 inch) and DermaCol Ag Silver Collagen Dressing (Model 00502E, 2x2 inch). All lots received between June 1, 2021 and September 30, 2021 are included in this recall.
The recall was initiated due to facility temperature excursions that occurred between June and August 2021, prior to product delivery. The dressings were exposed to higher temperatures during storage, which may have affected product effectiveness.
The FDA has determined that these devices with this specific storage temperature deviation are not likely to cause adverse health consequences.
The recalled product
- 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 Dress
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- 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 (5)
- GTIN: a. 01714196303447
- 00714196391322
- 00714196303448. b. 00714196391421
- 01714196502222
- 00714196502223
Distribution
Distributed nationwide across the United States.
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