Z-1737-2025 Class II Ongoing
FDA device recall Z-1737-2025 was initiated by Galt Medical Corporation on March 27, 2025 and is designated Class II. Reason for recall: Due to a potential open seal in the sterile barrier packaging. The recall status is ongoing. Affected quantity: 490 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2025
- Initiation Date
- March 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 490 units
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.
Reason for Recall
Due to a potential open seal in the sterile barrier packaging.
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.
Code Information
Catalog Number: KIT-051-01, UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15, UDI-DI code: 00841268107380 Lot Number: 24284447