Device product
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
Z-1732-2025
Product summary
- Event
- Event 96622
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,400 dilators
- Official record key
device-enforcement:Z-1732-2025
Official wording
Reason: Due to a potential open seal in the sterile barrier packaging .
Code information: KIT-018-47 UDI-DI code: 0404696432727 Lot Number: S25052261 KIT-019-67 UDI-DI code: 0404696432738 Lot Number: P25052052 KIT-018-41 UDI-DI code: 0404696432750 Lot Number: S25064124 KIT-019-37 UDI-DI code: 0404696432802 Lot Number: P25115062
Distribution pattern: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.
Derived failure modes
-
Labeling or packaging
open seal