Mckesson Medical-Surgical Inc. Corporate Office: a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamin

Is my product affected?

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 In

• UPC 01714196303447
• UPC 00714196391322
• UPC 00714196303448
• UPC 00714196391421
• UPC 01714196502222
• UPC 00714196502223

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling DermaCol Collagen Dressing products (including DermaCol Without Border and versions containing Collagen, Sodium Alginate, Carboxyl Methylcellulose, and Ethylenediamine) distributed nationwide. The recall affects all lots received between June 1, 2021 and September 30, 2021. The products were exposed to temperature excursions between June and August 2021 prior to delivery, which may have impacted product effectiveness. However, the manufacturer states that this specific storage temperature deviation is not likely to cause adverse health consequences.

The affected products have the following GTINs and lot codes: 01714196303447, 00714196391322, 00714196303448, 00714196391421, 01714196502222, and 00714196502223. The source document does not specify a remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: a. 12 b. 60 Lot/code info: GTIN: a. 01714196303447; 00714196391322; 00714196303448. b. 00714196391421; 01714196502222; 00714196502223

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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