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 sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).
FDA Recall Z-2054-2017 · Posted None
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Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHHW
Date Initiated2017-04-10
Date Terminated2017-11-01
Product Quantity7126 units (total for all products)
Reason for Recall
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
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, COLOMBIA, COSTA RICA, DENMARK, ENGLAND, GREECE, GUAM, ISRAEL, LITHUANIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, and SWEDEN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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