Z-1609-2025 Class II Ongoing
FDA device recall Z-1609-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on March 3, 2025 and is designated Class II. Reason for recall: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. The recall status is ongoing. Affected quantity: 40 units.
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
- 40 units
Product Description
Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
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) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24KBK455