MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
FDA Recall #Z-0565-2022 — Class II — December 22, 2021
Product Description
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 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
2652 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Code Information
1) Code 7160-20, Lots 30116959, 30132543, 30132545, and 30132546 2) Code 7640-20, Lots 30129345
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated