FDAFDA · Food and drugs·Recall number Z-1947-2014
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
Published July 9, 2014 · Recall initiated: May 16, 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
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Alcon Research, Ltd.
- Distributor
- Nationwide Distribution including North Carolina and Maine
- Lot
- Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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