Z-1605-2025 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
- 6 units
Product Description
Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
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) SUT15830A, UDI-DI: 10653160996750(each), 40653160996751(case), Lot Number: 24IBR642