Galt Medical Corporation: 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 o

Hazard

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

Details from the source

Reason for recall: Due to a potential open seal in the sterile barrier packaging . Distribution: 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. Quantity: 1,400 dilators 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

UPC codes

0404696432727, 0404696432738, 0404696432750, 0404696432802

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.