MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
FDA Recall #Z-0566-2022 — Class II — December 22, 2021
Product Description
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Reason for Recall
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Recalling Firm
Avanos Medical, Inc. — Alpharetta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
692 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Code Information
1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated