Recall record at a glance
| Official record | Z-2054-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | CooperSurgical, Inc. |
| Report date | May 17, 2017 |
| Recall initiation date | Apr 10, 2017 |
| Quantity | 7126 units (total for all products) |
| Location | Trumbull, CT, United States |
Official product description
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).
Why the product 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.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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