FDA-Device2023-06-14Class II

Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818

C.R. Bard Inc
Hazard

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.

Sold states
Worldwide
Affected count
9894922 devices
Manufactured in
8195 Industrial Blvd Ne, Covington, GA, United States
Products
Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2023

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