FDA-Device2023-06-14Class II
Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
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
7427880 devices
Manufactured in
8195 Industrial Blvd Ne, Covington, GA, United States
Products
Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1699-2023Don't want to check this manually?
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