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FDA (Device enforcement)Recalled 2022-05-25class iii

Mckesson Medical-Surgical Inc. Corporate Office: a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2

Is my product affected?

a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d. DERMA SCIENCES, INC Surgitu

  • UPC 809958001097
  • UPC 809958001103
  • UPC 00809958001127
  • UPC 00809958001141
  • UPC 00809958001165

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

What happened

Mckesson Medical-Surgical Inc. is recalling Surgitube Bandage Gauze products distributed nationwide between June 1, 2021 and September 30, 2021. The recall was initiated because these products were exposed to higher than appropriate temperatures at a facility between June and August 2021 prior to delivery, which may have impacted product effectiveness. However, the record states that this specific storage temperature deviation is not likely to cause adverse health consequences.

The affected products include Surgitube Bandage Gauze in white size 15/8" 50 yards (Catalog #GL-219) and size 2, with five different lot/code numbers identified. The source document does not specify a remedy or action that affected consumers should take.

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. 17 b. 7 c. 1 d. 2 e. 5 Lot/code info: GTIN: a. 809958001097. b. 809958001103. c. 00809958001127. d. 00809958001141. e. 00809958001165

Source

Official record: FDA (Device enforcement) ↗

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

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