FDA Medical Device · Z-1796-2022

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

Class III · Ongoing

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.

Affected lots / codes — check yours against thisGTIN: a. 01714196303447; 00714196391322; 00714196303448. b. 00714196391421; 01714196502222; 00714196502223

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Classification: Class III (unlikely to cause harm)
Status: Ongoing
Quantity: a. 12 b. 60
Distribution: US Nationwide distribution.
Recall initiated: May 25, 2022
Classified: September 26, 2022
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1796-2022%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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