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

Mckesson Medical-Surgical Inc. Corporate Office: a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrola

Is my product affected?

a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042. b. INTEGRA LIFESCIENCE (WND CARE) ALGICELL Ag Silver Alginate Dressing Algicell Ag 4 X 5 Inch Rectangle Ste

  • UPC 10381780491781
  • UPC 30381780491785
  • UPC 10381780491675
  • UPC 30381780491679

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

What happened

McKesson Medical-Surgical Inc. is recalling Shur-Conform Oil Emulsion Impregnated Dressing (3 x 8 inch) due to temperature excursions that occurred at a facility between June and August 2021, prior to delivery. The affected products were received between June 1, 2021 and September 30, 2021. Exposure to higher temperatures may have impacted the product's effectiveness. The recall involves 6 boxes and 308 cases distributed nationwide, identified by specific GTINs and lot codes.

According to the manufacturer, this device with the specific storage temperature deviation is not likely to cause adverse health consequences. The source does not specify a remedy or recommended action for consumers who may have affected products.

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. 6 bx b. 308 cs. Lot/code info: GTIN: a. 10381780491781 EA; 30381780491785 CS. b. 10381780491675 EA; 30381780491679 CS

Source

Official record: FDA (Device enforcement) ↗

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

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