Recall Z-1012-2013— Cooper Surgical, Inc.

Name: FDA recall Z-1012-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-26

Class III · Terminated

Class III FDA medical device recall by Cooper Surgical, Inc., initiated 2013-02-26, terminated 2014-03-04. It names 2 FDA 510(k) clearances: K904774, K904026. Product: Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 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.. Reason: Pessary mislabeled outer package may not reflect the size of the product contained in the package.

Recalling firm: Cooper Surgical, Inc.
Classification: Class III
Status: Terminated
Initiated: 2013-02-26
Terminated: 2014-03-04
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

Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 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.

Reason for recall

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

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