Z-0778-2023 Class II Ongoing
FDA device recall Z-0778-2023 was initiated by Steris Corporation on Dec 12, 2022 and is designated Class II. Reason for recall: Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as… The recall status is ongoing. Affected quantity: 338 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2023
- Initiation Date
- Dec 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 338 boxes
Product Description
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Reason for Recall
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
Distribution Pattern
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Code Information
UDI: 10724995023833 lot #230613
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0778-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026