Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814
FDA device recall Z-1698-2023 · posted 2023-06-08 · Open, Classified
Recall details
- Recalling firm
- C.R. Bard Inc
- 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.
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EZD
- Quantity affected
- 9894922 devices
- Distribution
- Worldwide
- Date initiated
- 2023-04-20
- Date posted
- 2023-06-08
- Location
- Covington, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Magic3 Go Intermittent Urinary Catheter (K150345) | C.R. Bard, Inc. | 2015-05-11 |