Recall Z-3074-2017 ยท FPD Tube, Feeding
Kentec Medical Inc
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 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 | K100526 |
| 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 |