Recall Z-1701-2023
C.R. Bard Inc · initiated April 20, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: a) REF 71808, Lot Numbers: JUGU9026; b) REF 71810, Lot Numbers: JUGT9154, JUGU9053, JUGV9130, JUGV9133; c) REF 71812, Lot Numbers: JUGT0236, JUGT1689, JUGT2702, JUGU1955, JUGU1968, JUGV9158; d) REF 71814, Lot Numbers: JUGT3326; e) REF 71816, Lot Numbers: JUGU9023; f) REF 71818, Lot Numbers: JUGT0288, JUGU9022
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.
FDA-determined 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
Details
- Recall number
- Z-1701-2023
- Initiated
- April 20, 2023
- Posted by FDA
- June 8, 2023
- Product code
- EZD – Catheter, Straight
- Quantity
- 308520 devices
- Distribution
- Worldwide
- Recalling firm
- C.R. Bard Inc, Covington, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1698-2023 Class II | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… | 04/20/2023Open, Classified |
| Z-1699-2023 Class II | Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… | 04/20/2023Open, Classified |
| Z-1700-2023 Class II | Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810GSome catheters had a manufacturing defect where the clear resealing label separating from the product foil… | 04/20/2023Open, Classified |