CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
This recall has been terminated (originally issued October 8, 2019).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- October 8, 2019
- Terminated
- March 16, 2022
- Recall Number
- Z-0370-2020
- Quantity
- 104 cases (208 units) total
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The connector piece to the PEG tube does not pass over the guidewire.
Distribution
Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
Lot / Code Info
Catalog Number: 30-4020 (Lot Numbers:0203145253, 0203081127); Catalog Number: 30-4320 (Lot Numbers: 0002994173, 0202974008, 0202907370, 0203201718, 0203241065)
Root Cause
Under Investigation by firm
Action Taken
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.