FDAFDA · Food and drugs·Recall number Z-0173-2025
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
Published October 30, 2024 · Recall initiated: September 4, 2024
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
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Lot
- a) REF DYNJ37909A, UDI/DI 40193489675451 (each), 10193489675450 (case), Lot Numbers: 24ABG035; b) REF DYNJ40040C, UDI/DI 40889942683971 (each), 10889942683970 (case), Lot Numbers: 23KBB863
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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