Recall Z-1814-2015 ยท HDW Diaphragm, Contraceptive (And Accessories)
CooperSurgical, Inc.
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
| Date | Jun 18, 2015 (initiated May 20, 2015) |
| Status | Terminated |
| Reason | A diaphragm size 80 labeled box was incorrectly packaged with a size 85. |
| Root cause | Labeling mix-ups |
| Action | CooperSurgical notified consignees by letter on 5/18/15 via Fedex with confirmed delivery receipt.. Accounts requested to discontinue use and complete the attached Acknowledgement and Receipt Form for replacement. CooperSurgical provided further instruction on the disposition of the product at the time of replacement If you have any further questions please feel free to contact 203.601.5200. . |
| Quantity | 200 units |
| Distribution | AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND |
| 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 |