medical Class II Updated 2025-05-14

Galt Medical Corporation recalls B Braun Interventional Coaxial Dilator REF: KIT-018-47, K

Recalled 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.

Hazard / Issue

Due to a potential open seal in the sterile barrier packaging .

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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