Recall Z-1699-2023— C.R. Bard Inc

Name: FDA recall Z-1699-2023
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: K172247. Product: 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. 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

K172247 — Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.·cleared 2017-09-20

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

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

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.