Z-1782-2014Class II

Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

Name: Z-1782-2014 Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Creator: CooperSurgical, Inc.
Published: 2014-05-13
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2014-05-13 / Terminated / root cause: manufacturing process

FDA source

CooperSurgical, Inc. began a recall of Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005 on 2014-05-13. FDA classified it as Class II and gives the reason as "Sterility of the device may be compromised due to unsealed pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1782-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-13
Posted: 2014-06-11
Terminated: 2015-05-28
Recalling firm: CooperSurgical, Inc.
Product: Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Product code: LKF Cannula, Manipulator/Injector, Uterine
Reason for recall: Sterility of the device may be compromised due to unsealed pouch
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cooper Surgical Inc notified consignees by letter dated 5/13/14 sent via Federal Express with confirmed delivery receipt. Consignees are requested to return for refund or exchange. If you have any further questions contact the firm at 203.601.5200.
Quantity in commerce: 1180 units
Distribution: Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.
Product codes and lots: Lot 141525

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1782-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1782-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-11

Product code LKF

K970492Class IIIntrauterine Insemination and Sonohysterography CatheterAckrad Laboratories / cleared 1997-04-09

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)