Galt Medical Corporation: Device Recall
Recall #Z-1737-2025 · 03/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1737-2025
- 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
- 490 units
Reason for Recall
Due to a potential open seal in the sterile barrier packaging.
Product Description
Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.
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.