Recall Z-1054-2016 ยท HDW Diaphragm, Contraceptive (And Accessories)
CooperSurgical, Inc.
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
| Date | Mar 4, 2016 (initiated Feb 16, 2016) |
| Status | Terminated |
| Reason | The products have been identified to contain an incorrect size Diaphragm. |
| Root cause | Package design/selection |
| 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 | 2 units |
| Distribution | US Distribution to the states of : OR and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS CooperSurgical, Inc., Jan 23, 2008 |