FDAFDA · Food and drugs·Recall number Z-0797-2013
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Published February 13, 2013 · Recall initiated: November 26, 2012
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
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Custom Healthcare Systems, Inc.
- Distributor
- USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
- Lot
- LOT NO. 60812 EXPIRES: 11 /2012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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