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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The connector piece to the PEG tube does not pass over the guidewire.

Recommended Action

Per FDA guidance

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 to 1-888-807-1084. Outside the USA, please send by email to avanos4178OUS@stericycle.com or by FAX to +44 (0) 20 7660 1462. For further assistance, please contact Avanos by email at avanos4178@stericycle.com or by FAX to 1-888-807-1084. Outside the USA, please send by email to avanos4178OUS@stericycle.com or by FAX to +44 (0) 20 7660 1462. You may also contact Avanos Customer Service at exportcustomercare@avanos.com.

Distribution

As reported by FDA

CT, IN, MD, NJ, PA, VA