Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patie
FDA device recall Z-1425-2016 · 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
- 35
- 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 |
|---|---|---|
| URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (K962652) | Customed, Inc. | 1996-10-04 |