FDA recall Z-0779-2023

Steris Corporation · Class II · device

Product

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

Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA

Key facts

Status: Ongoing
Initiation date: 2022-12-12
Report date: 2023-01-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0779-2023