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
- Company
- C.R. Bard, Inc.
- Recall Initiated
- April 20, 2023
- Posted
- June 8, 2023
- Recall Number
- Z-1701-2023
- Quantity
- 308520 devices
- Firm Location
- Covington, GA
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 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
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