Device 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
Z-1701-2023
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 92082
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 308520 devices
- Official record key
device-enforcement:Z-1701-2023
Official wording
Reason: 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.
Code information: 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
Distribution pattern: Worldwide
Derived failure modes
-
Manufacturing or process control
manufacturing defect