FDA Recall
Terminated
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.
Recall: Z-2080-2012
·
Initiated July 2, 2012
Recall
- Recall Number
- Z-2080-2012
- Event Number
- 62432
- Firm
- Beekley Corporation
- FEI Number
- 3000204334
- Product Code
- IZH
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 2, 2012
- Terminated
- July 9, 2013
- Address
- 1 Prestige Ln, Bristol, CT, 06010-7468
Description
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.
Reason
Imaging artifact can occur on mammogram result
Action
Beekley Medical issued "Urgent: Medical Device Recall" notifications dated June 29, 2012 that were sent via certified mail USPS on July 2, 2012. The product issue was was described and customers were provided the recommended actions. Customer Service number is 1-800-233-5539.
Distribution
International Distribution including Nationwide(USA), and the countries of Japan and Canada.
Quantity
86,000 units