POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-4
FDA device recall Z-3074-2017 · posted 2017-07-22 · Terminated
Recall details
- Recalling firm
- Kentec Medical Inc
- Reason for recall
- Inadequate detectability of radiopaque stripes
- Action taken
- The firm notified their consignees by telephone and email on 06/23/2017, and followed with a letter sent certified mail, on 07/07/2017. The letter instructed the consignee to cease use of the product, isolate it, and contact Kentec.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPD
- Quantity affected
- K100526
- Distribution
- TX, VA, IL, CA, KS
- Date initiated
- 2017-06-23
- Date posted
- 2017-07-22
- Date terminated
- 2020-04-14
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (K100526) | Kentec Medical, Inc. | 2010-04-22 |