Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
FDA device recall Z-1721-2019 · posted 2019-07-05 · Terminated
Recall details
- Recalling firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Reason for recall
- Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
- Action taken
- On July 13, 2018, Metrex Research Corp., a subsidiary of Kerr Corporation, sent URGENT NOTICE: Regimen Glutaraldehyde letters to their consignees instructing them to check their inventory and complete the enclosed Field Action Acknowledement and Product Return Form. Distributors were requested to conduct sub-recalls to their consignees.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 31904
- Distribution
- AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.
- Date initiated
- 2018-07-13
- Date posted
- 2019-07-05
- Date terminated
- 2021-05-05
- Location
- Orange, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| METRICIDE 28 (K931052) | Metrex Research Corp. | 1994-12-06 |