FDAFDA · Food and drugs·Recall number Z-1320-2014
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Published April 9, 2014 · Recall initiated: March 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The products are labeled as sterile but were not sterilized.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merit Medical Systems, Inc.
- Distributor
- Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
- Lot
- Lot Number H574228
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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