Medical Device Recall: 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 t
Galt Medical Corporation · March 27, 2025
Reason for Recall
Due to a potential open seal in the sterile barrier packaging .
Product Description
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.
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.
States Affected
NATIONWIDE
Quantity Affected
1,400 dilators
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1732-2025
Status: ongoing
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