🔍 RecallPedia

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).

Class I - Dangerous
🏥 Medical Devices Recalled: April 10, 2017 CooperSurgical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    142947 142948 142949 146348 153078 153079 157415 160844 166923 166924 166925 178346 178347 178348 182458 185831 185832 185834 185835 185836 211779 219502 139577 141310 142937 146344 150141 153064 153065 157402 160467 162612 166911 178317 183618 183619 185809 185810 185812 185814 211776 212978 218621 218622 135402 141313 142941 144528 153069 153070 157406 157407 160839 166915 166916 166917 178320 178321 178322 178323 185818 185822 185823 185824 201919 212980 215758 121937 142944 144530 153074 157411 160842 178332 178333 178334 178335 182453 185826 185827 218669 139581 139582 139583 142946 144532 146347 153076 153077 157414 178343 178344 182455 182456 182457 200176 212983 215760
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
CooperSurgical, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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).

Product Codes/Lot Numbers:

142947 142948 142949 146348 153078 153079 157415 160844 166923 166924 166925 178346 178347 178348 182458 185831 185832 185834 185835 185836 211779 219502 139577 141310 142937 146344 150141 153064 153065 157402 160467 162612 166911 178317 183618 183619 185809 185810 185812 185814 211776 212978 218621 218622 135402 141313 142941 144528 153069 153070 157406 157407 160839 166915 166916 166917 178320 178321 178322 178323 185818 185822 185823 185824 201919 212980 215758 121937 142944 144530 153074 157411 160842 178332 178333 178334 178335 182453 185826 185827 218669 139581 139582 139583 142946 144532 146347 153076 153077 157414 178343 178344 182455 182456 182457 200176 212983 215760

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2054-2017

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