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

Mckesson Medical-Surgical Inc. Corporate Office: a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCe

Is my product affected?

a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biological Indicator Pack St

  • UPC 00724995161569
  • UPC 10724995161566
  • UPC 00724995084653
  • UPC 10724995084650
  • UPC 00724995023867
  • UPC 10724995023864
  • UPC 00724995154233
  • UPC 10724995154230
  • UPC 00724995161552
  • UPC 10724995161559
  • UPC 00724995002558

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

What happened

McKesson Medical-Surgical Inc. is recalling STERIS Corporation Celerity 20 Sterilization Indicator Challenge Pack Steam products (3 inch length, model LCB053) and STERIS Verify SixCe products that were received between June 1, 2021, and September 30, 2021. The products were exposed to higher temperatures during storage at the facility between June and August 2021, which may have impacted their effectiveness as sterilization indicators.

The recall affects products distributed nationwide. The source document does not specify a remedy or recommended action for consumers who have purchased or received 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.

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. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1 Lot/code info: GTIN: a. 00724995161569; 10724995161566. b. 00724995084653; 10724995084650. c. 00724995023867; 10724995023864. d. 00724995154233; 10724995154230. e. 00724995161552; 10724995161559. f. 00724995002558.

Source

Official record: FDA (Device enforcement) ↗

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

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