Z-0779-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2023
- Initiation Date
- December 12, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 857 boxes
Product Description
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 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, 50724995023824 lot #230613