Device product
Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
Z-1700-2023
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 92082
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5760 devices
- Official record key
device-enforcement:Z-1700-2023
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 52810G, UDI/DI 00801741136870, Lot Numbers: JUGW1445
Distribution pattern: Worldwide
Derived failure modes
-
Manufacturing or process control
manufacturing defect