| Date Initiated by Firm | February 16, 2016 |
|---|
| Date Posted | March 04, 2016 |
|---|
| Recall Status1 |
Terminated 3 on March 29, 2016 |
| Recall Number | Z-1054-2016 |
|---|
| Recall Event ID |
73329 |
| 510(K)Number | K063223 |
|---|
| Product Classification |
Diaphragm, contraceptive (and accessories) - Product Code HDW
|
| Product | Milex Arcing Diaphragm Size 95; Model Number: MXWS95 |
|---|
| Code Information |
Lot# 130438 |
Recalling Firm/
Manufacturer |
CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
|
| For Additional Information Contact |
203-601-9818 |
|---|
Manufacturer Reason
for Recall | The products have been identified to contain an incorrect size Diaphragm. |
|---|
FDA Determined
Cause 2 | Package design/selection |
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| Action | Cooper Surgical sent an "Urgent - Medical Device Recall" letter dated February 16, 2016, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer.
Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt form for replacement.
For further questions, please call (203) 601-9818. |
|---|
| Quantity in Commerce | 2 units |
|---|
| Distribution | US Distribution to the states of : OR and NY |
|---|
| 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 = HDW
|
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