Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
This recall is currently active, issued June 8, 2023. It was issued by C.R. Bard, Inc..
- Company
- C.R. Bard, Inc.
- Recall Initiated
- April 20, 2023
- Posted
- June 8, 2023
- Recall Number
- Z-1700-2023
- Quantity
- 5760 devices
- Firm Location
- Covington, GA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide
Lot / Code Info
a) REF 52810G, UDI/DI 00801741136870, Lot Numbers: JUGW1445
Root Cause
Under Investigation by firm
Action Taken
The firm issued an URGENT MEDICAL DEVICE RECALL to its consignee beginning on 04/20/2023 by Fed Ex and email. The notice explained the problem, risk, and requested the following actions be taken: Discontinue distribution of the product and dispose of all affected product, Distributors are directed to notify their customers. For further assistance please contact: 1-844-8BD- LIFE (1-844-823-5433) Say "Recall" when prompted; M-F 8am - 5pm CT