CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
Recall
- Recall Number
- Z-0371-2020
- Event Number
- 84021
- Firm
- Avanos Medical, Inc.
- FEI Number
- 3011270181
- Product Code
- KNT
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- October 8, 2019
- Terminated
- March 16, 2022
- Address
- 5405 Windward Pkwy, Alpharetta, GA, 30004-3894
Description
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
The connector piece to the PEG tube does not pass over the guidewire.
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 [email protected] or by FAX to 1-888-807-1084. Outside the USA, please send by email to [email protected] or by FAX to +44 (0) 20 7660 1462. For further assistance, please contact Avanos by email at [email protected] or by FAX to 1-888-807-1084. Outside the USA, please send by email to [email protected] or by FAX to +44 (0) 20 7660 1462. You may also contact Avanos Customer Service at [email protected].
Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
104 cases (208 units) total