FDA recall Z-1700-2023

Product

Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G

Reason for recall

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

Distribution

Worldwide

Key facts

Status

Ongoing

Initiation date

2023-04-20

Report date

2023-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1700-2023