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

Mckesson Medical-Surgical Inc. Corporate Office: a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model

Is my product affected?

a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.

  • UPC 00707387508296
  • UPC 00707387457037
  • UPC 50707387508291
  • UPC 30707387508297
  • UPC 30707387457038
  • UPC 50707387788006
  • UPC 30707387788002
  • UPC 00707387788001

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

What happened

McKesson Medical-Surgical Inc. is recalling two 3M Attest indicator products: Comply Indicator, Comply Vapor Gas (Model 1248) and Attest Indicator, Chemical Vaporized Hydrogen Peroxide. The recall affects products with specific lot codes that were received between June 1, 2021 and September 30, 2021. These products experienced temperature excursions at the facility between June and August 2021 prior to delivery, which may have impacted their effectiveness.

The affected products were distributed nationwide. The source document does not specify a remedy for consumers who have received these 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.

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. Distribution: US Nationwide distribution. Quantity: a. 12 bags, b. 4 bags Lot/code info: GTIN: a. 00707387508296; 00707387457037; 50707387508291; 30707387508297; 30707387457038. b. 50707387788006; 30707387788002; 00707387788001.

Source

Official record: FDA (Device enforcement) ↗

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

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