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Mckesson Medical-Surgical Inc. Corporate Office recalls a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylc
Recalled October 5, 2022 · FDA recall Z-1796-2022 · Mckesson Medical-Surgical Inc. Corporate Office
Hazard
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. · FDA Class III
Units
a. 12 b. 60
Sold at
US Nationwide distribution.
Description
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.
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 Dressing DermaCol/Ag 2 X 2 Inch Square Sterile Model Number: 00502E
Manufacturer(s)
Mckesson Medical-Surgical Inc. Corporate Office
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →