Recall Z-0605-2014— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2013-09-10, terminated 2014-02-14. It names 3 FDA 510(k) clearances: K083665, K854631, K854902. Product: VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.. Reason: STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-10
- Terminated
- 2014-02-14
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
3 on FDA's record- K083665 — VERIFY SCBI 275F 3-10
- K854631 — ASSERT EO BIOLOGICAL TEST PACK
- K854902 — SURGICOT STEAM TEST PACK
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
Reason for recall
STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.
Data sourced from openFDA. This site is unofficial and independent of the FDA.