Z-1700-2023 Class II Ongoing
FDA device recall Z-1700-2023 was initiated by C.R. Bard Inc on April 20, 2023 and is designated Class II. 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 s… The recall status is ongoing. Affected quantity: 5760 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2023
- Initiation Date
- April 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5760 devices
Product Description
Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
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 Pattern
Worldwide
Code Information
a) REF 52810G, UDI/DI 00801741136870, Lot Numbers: JUGW1445