FDAFDA · Food and drugs·Recall number Z-1605-2025
Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
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) SUT15830A, UDI-DI: 10653160996750(each), 40653160996751(case), Lot Number: 24IBR642
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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