Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to
FDA device recall Z-1475-2016 · 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
- FYA
- Quantity affected
- 1148
- 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 |
|---|---|---|
| GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) (K971920) | Customed, Inc. | 1997-12-04 |