Recall Z-2054-2017— CooperSurgical, Inc.

Name: FDA recall Z-2054-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-10

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2017-04-10, terminated 2017-11-01. It names 2 FDA 510(k) clearances: K904774, K904026. Product: 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).. 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..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Terminated: 2017-11-01
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

2 on FDA's record

K904774 — INGLAT-O-BALLMilex Products, Inc.·cleared 1990-12-07
K904026 — INFLAT-O-BALLMilex Products, Inc.·cleared 1990-10-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.