PlainRecalls
FDA Devices Low Class III Ongoing

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 Steam Model Number: S3069. d. STERIS CORP Celerity Celerity Sterilization Biological Indicator Vial Vaporized Hydrogen Peroxide Model Number:LCB044. e. STERIS CORP Celerity Celerity 20 Steril

Reported: October 5, 2022 Initiated: May 25, 2022 #Z-1793-2022

Product Description

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 Steam Model Number: S3069. d. STERIS CORP Celerity Celerity Sterilization Biological Indicator Vial Vaporized Hydrogen Peroxide Model Number:LCB044. e. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB049. f. STERIS CORP VERIFY Sterilization Indicator Challenge Pack Steam Catalog #LCB035.

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.

Details

Units Affected
a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1
Distribution
US Nationwide distribution.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled? ▼
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 Steam Model Number: S3069. d. STERIS CORP Celerity Celerity Sterilization Biological Indicator Vial Vaporized Hydrogen Peroxide Model Number:LCB044. e. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB049. f. STERIS CORP VERIFY Sterilization Indicator Challenge Pack Steam Catalog #LCB035.. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Low. Recall number: Z-1793-2022.

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