Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1006-2013 — Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 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.

U.S. FDA — Device Enforcement · United States · 2013-02-26 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1006-2013
Date of alert
2013-02-26
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Cooper Surgical, Inc.
Product category
device
Product type
Devices
Reported risk: Pessary mislabeled outer package may not reflect the size of the product contained in the package
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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