Date Initiated by Firm |
February 09, 2015 |
Date Posted |
March 03, 2015 |
Recall Status1 |
Terminated 3 on January 15, 2016 |
Recall Number |
Z-1239-2015 |
Recall Event ID |
70502 |
510(K)Number |
K904026
|
Product Classification |
Pessary, vaginal - Product Code HHW
|
Product |
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 |
Code Information |
Lot numbers: 144351, 142789 |
Recalling Firm/ Manufacturer |
CooperSurgical, Inc. 75 Corporate Dr Trumbull CT 06611-1350
|
For Additional Information Contact |
Same 203-601-5200
|
Manufacturer Reason for Recall |
Incorrect size printed on the Milex Pessary Kit packaging label
|
FDA Determined Cause 2 |
Error in labeling |
Action |
CooperSurgical sent an Recall Letter dated February 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter asked customers to contact CooperSurgical Product Surveillance Department if they had any questions.
At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement.
Questions contact CooperSurgical 203.601.5200. |
Quantity in Commerce |
95 units |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = HHW and Original Applicant = MILEX PRODUCTS, INC.
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