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.
Reported: May 14, 2025 Initiated: March 27, 2025 #Z-1732-2025
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.
Reason for Recall
Due to a potential open seal in the sterile barrier packaging .
Details
- Recalling Firm
- Galt Medical Corporation
- Units Affected
- 1,400 dilators
- 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.
- Location
- Garland, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Galt Medical Corporation. Units affected: 1,400 dilators.
Why was this product recalled? ▼
Due to a potential open seal in the sterile barrier packaging .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2025. Severity: Moderate. Recall number: Z-1732-2025.
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