Z-0566-2022 Class II Terminated
FDA device recall Z-0566-2022 was initiated by Avanos Medical, Inc. on December 22, 2021 and is designated Class II. Reason for recall: The External Retention Bolster contained in the kit may be a larger diameter than the tube. The recall status is terminated (terminated August 15, 2023). Affected quantity: 692 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- December 22, 2021
- Termination Date
- August 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 692 units
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.
Distribution Pattern
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