Recall Z-0370-2020 ยท KNT Tubes, Gastrointestinal (And Accessories)
Avanos Medical, Inc.
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
| Date | Oct 8, 2019 |
| Status | Terminated |
| Reason | The connector piece to the PEG tube does not pass over the guidewire. |
| Root cause | Under Investigation by firm |
| Action | Avanos Medical notified customers of the recall on about 10/08/2019, via "URGENT: PRODUCT RECALL" letter. Customers were informed that there is a potential where the PEG tube does not pass over the guidewire. Instructions included to evaluate your inventory for any affected products, discontinue use of any affected product, quarantine any on hand, and arranged for the return of affected product. Customers were also instructed to complete the provide Recall Acknowledgement Form (Attachment 1) and return a copy of the form to Avanos in the USA by email to avanos4178@stericycle.com or by FAX |
| Quantity | 104 cases (208 units) total |
| Distribution | Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE Corpak Co., Sep 21, 1988 |