FDA Enforcement
Class II
Ongoing
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Recall: Z-1587-2025
·
Reported April 23, 2025
Enforcement
- Recall Number
- Z-1587-2025
- Event ID
- 96510
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 23, 2025
- Initiation Date
- March 3, 2025
- Classification Date
- April 17, 2025
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Reason
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Code Info
1) DYNJ84116A, UDI-DI: 10198459062438(each), 40198459062439(case), Lot Number: 24IBH580
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Quantity
60 units