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Terminated

Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

FDA Recall Z-1009-2013 · Posted 2013-03-27

Recalling FirmCooper Surgical, Inc.
Recall StatusTerminated
Product CodeHHW
Date Initiated2013-02-26
Date Terminated2014-03-04
Product Quantity275 units

Reason for Recall

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Firm Action

Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974. For questions regarding this recall call 203-601-9825.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K904774INGLAT-O-BALLMilex Products, Inc. · 1990-12-07K904026INFLAT-O-BALLMilex Products, Inc. · 1990-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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