Recall Z-3073-2017 ยท FPD Tube, Feeding
Kentec Medical Inc
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
| Date | Jul 22, 2017 (initiated Jun 23, 2017) |
| Status | Terminated |
| Reason | Inadequate detectability of radiopaque stripes |
| Root cause | Process control |
| Action | 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. |
| Quantity | 54 boxes of 10 individual units |
| Distribution | TX, VA, IL, CA, KS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE Kentec Medical, Inc., Apr 22, 2010 |