FDA-Device2023-06-14Class II
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
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
308520 devices
Manufactured in
8195 Industrial Blvd Ne, Covington, GA, United States
Products
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1701-2023Don't want to check this manually?
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