FDAFDA · Food and drugs·Recall number Z-1587-2025
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Published April 23, 2025 · Recall initiated: March 3, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
- Lot
- 1) DYNJ84116A, UDI-DI: 10198459062438(each), 40198459062439(case), Lot Number: 24IBH580
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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