Z-1732-2014Class II

RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park...

Name: Z-1732-2014 RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park...
Creator: Teleflex Medical
Published: 2014-05-21
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-05-21 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted... on 2014-05-21. FDA classified it as Class II and gives the reason as "Product was packaged with a straight catheter rather than the correct coude (curved) catheter". 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-1732-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-21
Posted: 2014-06-09
Terminated: 2015-11-23
Recalling firm: Teleflex Medical
Product: RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
Product code: KOD Catheter, Urological
Reason for recall: Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: Teleflex Medical sent an Urgent Medical Device Recall Notification dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any of the affected product in stock. They were to complete and return the enclosed Recall Acknowledgement Form via fax to Teleflex Medical. Upon receipt, they will be contacted by a Customer Service Representative with instructions for the return of the product to Teleflex Medical. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 1000 eaches
Distribution: US Distribution including the states of CA, FL, OH and OK.
Product codes and lots: Product Code: ECK103, Lot number: 02A1402484

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1732-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1732-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09

Product code KOD

K000070Class IIFlocathRusch Intl. / cleared 2000-02-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)