Recall Z-1701-2023— C.R. Bard Inc

Name: FDA recall Z-1701-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-20

Class II · Ongoing

Class II FDA medical device recall by C.R. Bard Inc, initiated 2023-04-20. It names one FDA 510(k) clearance: K150345. Product: 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. Reason: 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..

Recalling firm: C.R. Bard Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-04-20
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K150345 — Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.·cleared 2015-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.