Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)

The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.

On 01/21/2021, CooperSurgical issued Urgent Medical Device Recall notices to customers via certified mail. On 9/08/2021, CooperSurgical expanded the recall adding an additional lot and notified customers via courier service. Customers were advised to: - Discontinue use of and isolate all products subject to the recall. - Complete the Acknowledgement and Receipt Form, and return via email to [email protected] or fax to 203-601-9870. - Once the Acknowledgement Form is received, Cooper Surgical will arrange for Product replacement(s) and return of affected Product(s). The replacement Product(s) will be charged at the same price as the original order and your account will be credited back once the affected Product(s) are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same Form to indicate that and return it to CooperSurgical. Customers with questions, please call 203-601-5200 ext. 3300.