Z-0566-2022Class II

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

Name: Z-0566-2022 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Creator: Avanos Medical, Inc.
Published: 2021-12-22
License: https://open.fda.gov/license/

Halyard Health / initiated 2021-12-22 / Terminated

FDA source

Avanos Medical, Inc. began a recall of MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL on 2021-12-22. FDA classified it as Class II and gives the reason as "The External Retention Bolster contained in the kit may be a larger diameter than the tube". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0566-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-22
Posted: 2022-02-07
Terminated: 2023-08-15
Recalling firm: Halyard Health
Product: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The External Retention Bolster contained in the kit may be a larger diameter than the tube.
FDA root cause: Under Investigation by firm
Action: All USA Distributors and healthcare facilities that were directly shipped impacted devices were sent a Product Advisory Notice beginning on December 22, 2021 by email. Clinical Consignees were instructed to evaluate their facilities inventory of products to determine if any of the impacted product codes were present in their facility. The letter provided information identifying the affected product. It was indicated to segregate and return impacted product. The clinician may recognize that the External Retention Bolster is too large for the accompanying PEG tube when initially use the product. Consignees were instructed to complete an Acknowledgement Form and return a copy of the form to Avanos within five (5) days.
Quantity in commerce: 692 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Product codes and lots: 1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0566-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0565-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-07
Z-0566-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-07

Product code KNT

K924065Class IIMic Peg TubeMedical Innovations Corp. / cleared 1994-02-17

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)