Z-1012-2013Class III

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

Name: Z-1012-2013 Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a...
Creator: Cooper Surgical, Inc.
Published: 2013-02-26
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2013-02-26 / Terminated / root cause: packaging

FDA source

Cooper Surgical, Inc. began a recall of 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... on 2013-02-26. FDA classified it as Class III and gives the reason as "Pessary mislabeled outer package may not reflect the size of the product contained in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1012-2013
Classification: Class III
Status: Terminated
Initiated: 2013-02-26
Posted: 2013-03-27
Terminated: 2014-03-04
Recalling firm: CooperSurgical, Inc.
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.
Product code: HHW Pessary, Vaginal
Reason for recall: Pessary mislabeled outer package may not reflect the size of the product contained in the package
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
Product codes and lots: Lot Number:121784

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1012-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1004-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27
Z-1005-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27
Z-1006-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27
Z-1007-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27
Z-1008-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27
Z-1009-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27
Z-1010-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27
Z-1011-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27
Z-1012-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27

Product code HHW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)