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Class 3 Device Recall 0SPOT Mammography Skin Markers (REF 652) |
 |
| Date Initiated by Firm |
May 08, 2017 |
| Create Date |
June 27, 2017 |
| Recall Status1 |
Terminated 3 on June 20, 2017 |
| Recall Number |
Z-2309-2017 |
| Recall Event ID |
77295 |
| Product Classification |
System, x-ray, film marking, radiographic - Product Code JAC
|
| Product |
Beekley Medical 0-SPOT Mammography Skin Markers
REF 652 |
| Code Information |
LOT 652.04251701 |
Recalling Firm/
Manufacturer |
Beekley Corporation
1 Prestige Ln
Bristol CT 06010-7468
|
| For Additional Information Contact |
SAME
800-233-5539
|
Manufacturer Reason
for Recall |
Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels
|
FDA Determined
Cause 2 |
Employee error |
| Action |
Beekley Medical issued letter dated May 8, 2017 advised user of the problem and to examine inventory and return product.C Accounts requested to complete response form . Questions: Quality Assurance & Regulatory Manager at 1-800-233-5539 x 434. |
| Quantity in Commerce |
104 boxes (58/box)= 6,032 total units |
| Distribution |
US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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