Z-2163-2017Class II

CORFLO PEG Kit, Pull 16FR

Name: Z-2163-2017 CORFLO PEG Kit, Pull 16FR
Creator: CORPAK MedSystems, Inc.
Published: 2017-02-03
License: https://open.fda.gov/license/

Halyard Health / initiated 2017-02-03 / Terminated / root cause: design

FDA source

CORPAK MedSystems, Inc. began a recall of CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG... on 2017-02-03. FDA classified it as Class II and gives the reason as "Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2163-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-03
Posted: 2017-05-25
Terminated: 2019-08-05
Recalling firm: Halyard Health
Product: CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Root cause tag: design
FDA root cause: Device Design
Action: Firm provided consignees with field correction on 2/2/2017 by letter mailed via FedEx. Within the notice, the firm provided additional instructions for handling the PEG Y-Adapter to help reduce the likelihood for exposing the stem to excess stress that could break the connector. Consignees were instructed to forward the field correction notice to all staff members or end-users who use the ENFit Y-Adapter.
Quantity in commerce: 8 cases (2 units per case)
Distribution: Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
Product codes and lots: Catalogue Numbers: 50-6016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2163-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2161-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-24
Z-2162-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-24
Z-2163-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)