Z-1793-2022 Class III Ongoing
FDA device recall Z-1793-2022 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on May 25, 2022 and is designated Class III. 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. The recall status is ongoing. Affected quantity: a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 5, 2022
- Initiation Date
- May 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1
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.
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN: a. 00724995161569; 10724995161566. b. 00724995084653; 10724995084650. c. 00724995023867; 10724995023864. d. 00724995154233; 10724995154230. e. 00724995161552; 10724995161559. f. 00724995002558.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1793-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026