Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization
FDA device recall Z-1867-2013 · posted 2013-08-01 · Terminated
Recall details
- Recalling firm
- Mesa Laboratories, Inc., Bozeman Manufacturing Facility
- Reason for recall
- Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
- Action taken
- Mesa Labs sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions contact Mesa Labs at BI-Support@mesalabs.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRC
- Quantity affected
- 865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherl
- Date initiated
- 2013-06-04
- Date posted
- 2013-08-01
- Date terminated
- 2013-11-22
- Location
- Bozeman, MT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EZTEST (K963841) | Sgm Biotech, Inc. | 1997-02-25 |
| EZTEST-STEAM (K930682) | Sgm Biotech, Inc. | 1994-04-04 |