Reported May 17, 2017 · Terminated
CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary…
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit
- Product UsageThe 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)
- Lot codes and dates
98 of 98 codes
142947142948142949146348153078153079157415160844166923166924166925178346178347178348182458185831185832185834185835185836211779219502139577141310142937146344150141153064153065157402160467162612166911178317183618183619185809185810185812185814211776212978218621218622135402141313142941144528153069153070157406157407160839166915166916166917178320178321178322178323
- Amount recalled
- 7126 units (total for all products)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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