FDA recall Z-0565-2022

Product

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada and Chile.

Key facts

Status

Terminated

Initiation date

2021-12-22

Report date

2022-02-16

Termination date

2023-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2022