VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use
FDA device recall Z-0605-2014 · posted 2013-12-28 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- 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.
- Action taken
- On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.
- Root cause
- Use error
- Status
- Terminated
- Product code
- FRC
- Quantity affected
- 1,238 boxes
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AK, Al, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH,
- Date initiated
- 2013-09-10
- Date posted
- 2013-12-28
- Date terminated
- 2014-02-14
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERIFY SCBI 275F 3-10 (K083665) | STERIS Corporation | 2009-09-01 |
| ASSERT EO BIOLOGICAL TEST PACK (K854631) | Surgicot, Inc. | 1986-05-27 |
| SURGICOT STEAM TEST PACK (K854902) | Surgicot, Inc. | 1986-05-20 |