TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures suc
FDA device recall Z-2565-2015 · posted 2015-09-03 · 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
- Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- NXA
- Quantity affected
- 3550 kits
- Distribution
- Distributed Only in Puerto Rico.
- Date initiated
- 2015-07-10
- Date posted
- 2015-09-03
- Date terminated
- 2017-04-12
- 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 |
|---|---|---|
| TRACHEOSTOMY CARE KIT (STERILE) (K925020) | Customed, Inc. | 1993-07-07 |