Z-1590-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,118 units
Product Description
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
Reason for Recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Code Information
1) DYNJHTCAD1, UDI-DI: 10888277087583(each), 40888277087584(case), Lot Number: 24JBS743; 2) DYNJ05350V, UDI-DI: 10193489316629(each), 40193489316620(case), Lot Number: 24JBU500; 3) DYNJ38144C, UDI-DI: 10193489854916(each), 40193489854917(case), Lot Number: 24KBD294