FDAFDA · Food and drugs·Recall number Z-2080-2012
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
Published August 1, 2012 · Recall initiated: July 2, 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
Imaging artifact can occur on mammogram result
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beekley Corporation
- Distributor
- International Distribution including Nationwide(USA), and the countries of Japan and Canada.
- Lot
- Lot Numbers: 107657, 108150, 108833
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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