Recall Z-2054-2017 ยท HHW Pessary, Vaginal
CooperSurgical, Inc.
CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed seale
| Date | Apr 10, 2017 |
| Status | Terminated |
| Reason | The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber. |
| Root cause | Error in labeling |
| Action | CooperSurgical sent a recall notification dated April 10, 2017 to all affected customers. The letter identified the product problem and the action needed to be taken by the customer. |
| Quantity | 7126 units (total for all products) |
| Distribution | Worldwide Distributed - US Nationwide in the states of: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN, KS,KY,LA,MA,MD, ME, MI, MN, MO, MS, MT, NC,ND,NE, N H, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and countries of: AUSTRALI A,BAHAMAS,BRAZIL,CANADA, COLOM |
| FDA record | Open on fda.gov |