FDA-Device2025-05-14Class II
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.
Galt Medical Corporation
Hazard
Due to a potential open seal in the sterile barrier packaging .
Sold states
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.
Affected count
1,400 dilators
Manufactured in
2220 Merritt Dr, N/A, Garland, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1732-2025Don't want to check this manually?
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