Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammogr
FDA device recall Z-1787-2014 · posted 2014-06-13 · Terminated
Recall details
- Recalling firm
- Beekley Corporation
- Reason for recall
- Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
- Action taken
- Beekley sent an Urgent Medical Device Recall letters dated June 19, 2013 via FedEx with signature and tracking confirmation. The letter identified the affected product, problem and actions to be taken. Firm requests users to examine inventory, remove and return recalled product. For questions contact Chelsea Fuller, Regulatory Manager at 1-800-233-5539 x 491
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 81 boxes
- Distribution
- Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA.
- Date initiated
- 2013-06-19
- Date posted
- 2014-06-13
- Date terminated
- 2014-06-16
- Location
- Bristol, CT
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