PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 14, 2023 Initiated: April 20, 2023 #Z-1698-2023

Product Description

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

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.

Details

Recalling Firm
C.R. Bard Inc
Units Affected
9894922 devices
Distribution
Worldwide
Location
Covington, GA

Frequently Asked Questions

What product was recalled?
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. Recalled by C.R. Bard Inc. Units affected: 9894922 devices.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 14, 2023. Severity: Moderate. Recall number: Z-1698-2023.