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

Mckesson Medical-Surgical Inc. Corporate Office: a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTIONS McKesson

Is my product affected?

a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.75 (10/BX 10BX/CS Catalog #177400. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHI

  • UPC 00612479243545
  • UPC 00612479253049
  • UPC 00612479253056
  • UPC 00612479253063
  • UPC 00612479253025
  • UPC 00612479253032
  • UPC 00612479253018

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

What happened

McKesson Medical-Surgical Inc. recalled Advanced Medical Solutions McKesson wound gelling fiber dressings (4"x4 3/4", 10 per box) due to temperature excursions that occurred at a facility between June and August 2021, prior to delivery. Products with lot codes received between June 1, 2021 and September 30, 2021 were affected. The exposure to higher temperatures may have impacted product effectiveness, though the manufacturer stated this specific storage temperature deviation is not likely to cause adverse health consequences. The recall affected products distributed nationwide.

The recall notice does not specify a remedy 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. .03bx b. 204bx c. 34bx Lot/code info: GTIN: a. 00612479243545. b. 00612479253049; 00612479253056 BX; 00612479253063 CS; c. 00612479253025; 00612479253032; 00612479253018

Source

Official record: FDA (Device enforcement) ↗

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

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