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Recall Observatory FDA recall evidence

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

March 27, 2025

Class II

Product summary

Firm
Galt Medical Corporation
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

    reason.labeling_packaging · v1.0.0

    open seal