Galt Medical Corporation: Device Recall
Recall #Z-1735-2025 · 03/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1735-2025
- 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
- 4,280 kits
Reason for Recall
Due to a potential open seal in the sterile barrier packaging.
Product Description
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral 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.