FDA Medical Device Recalls (openFDA)
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 number
- Z-0370-2020
- Recalling firm
- Avanos Medical, Inc.
- Product
- CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
- Status
- Terminated
- Initiated
- 2019-10-08
- Posted
- not on file
- Terminated
- 2022-03-16
- 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 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.
- Quantity
- 104 cases (208 units) total
- Distribution
- Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
- Lot, serial or model codes
- Catalog Number: 30-4020 (Lot Numbers:0203145253, 0203081127); Catalog Number: 30-4320 (Lot Numbers: 0002994173, 0202974008, 0202907370, 0203201718, 0203241065)
- 510(k) numbers
- ["K882867"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28