Z-2570-2014Class II

CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography

Name: Z-2570-2014 CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography
Creator: CooperSurgical, Inc.
Published: 2014-07-03
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2014-07-03 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography on 2014-07-03. FDA classified it as Class II and gives the reason as "Unsealed pouches". 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-2570-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-03
Posted: 2014-09-05
Terminated: 2015-05-28
Recalling firm: CooperSurgical, Inc.
Product: CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Product code: LKF Cannula, Manipulator/Injector, Uterine
Reason for recall: Unsealed pouches.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Customer notification letter was sent on July 1, 2014 via UPS with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers may have on hand. For questions contact James Keller, Vice President, Regulatory Affairs/Quality Assurance at 203-601-5200.
Quantity in commerce: 1,400 units
Distribution: Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.
Product codes and lots: Lot 153914

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2570-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2570-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-05

Product code LKF

K020951Class IIH/s Catheter Set (5F), Model 61-5005; H/s Catheter Set (7F), Model 61-5007Ackrad Laboratories / cleared 2002-04-16

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)