Galt Medical Corporation: Device Recall
Recall #Z-1732-2025 · 03/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1732-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Galt Medical Corporation
- Status
- Ongoing
- Date Initiated
- 03/27/2025
- Location
- Garland, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,400 dilators
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 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.
Other Recalls by Galt Medical Corporation
- Class II: Risk 03/27/2025
- Class II: Risk 03/27/2025
- Class II: Risk 03/27/2025
- Class II: Risk 03/27/2025
- Class II: Risk 03/27/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.