FDAFDA · Food and drugs·Recall number Z-1805-2015
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
Published June 24, 2015 · Recall initiated: May 1, 2015
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
Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beaver-Visitec International Inc.
- Distributor
- Nationwide Distribution including KY, GA, MI, and NJ.
- Lot
- Lot Numbers: 3045852 3053258 3063193 3068829
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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