Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedu
FDA device recall Z-1466-2016 · posted 2016-04-14 · Terminated
Recall details
- Recalling firm
- Customed, Inc
- Reason for recall
- Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Action taken
- Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 55
- Distribution
- Distributed only in Puerto Rico.
- Date initiated
- 2016-01-07
- Date posted
- 2016-04-14
- Date terminated
- 2017-05-03
- Location
- Fajardo, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUSTOMED BASIC PACK III (K902886) | Customed, Inc. | 1990-09-19 |