Z-0371-2020Class II

CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2...

Name: Z-0371-2020 CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2...
Creator: Avanos Medical, Inc.
Published: 2019-10-08
License: https://open.fda.gov/license/

Halyard Health / initiated 2019-10-08 / Terminated

FDA source

Avanos Medical, Inc. began a recall of CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as... on 2019-10-08. FDA classified it as Class II and gives the reason as "The connector piece to the PEG tube does not pass over the guidewire". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0371-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-08
Posted: 2019-11-14
Terminated: 2022-03-16
Recalling firm: Halyard Health
Product: 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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The connector piece to the PEG tube does not pass over the guidewire.
FDA 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 [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].
Quantity in commerce: 104 cases (208 units) total
Distribution: Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
Product codes and lots: Catalog Number: 50-4016E1 (Lot Numbers:0203137961, 0203172166); Catalog Number: 50-4020E1 (Lot Number: 0203069043)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0371-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0370-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0371-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14

Product code KNT

K882867Class IICorpak Percutaneous Endoscopic Gastrostomy TubeCorpak Co. / cleared 1988-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)