Recall Z-1239-2015 ยท HHW Pessary, Vaginal
CooperSurgical, Inc.
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
| Date | Mar 3, 2015 (initiated Feb 9, 2015) |
| Status | Terminated |
| Reason | Incorrect size printed on the Milex Pessary Kit packaging label |
| Root cause | 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 | 95 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904026 | INFLAT-O-BALL Milex Products, Inc., Oct 10, 1990 |