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.
FDA Recall Z-1732-2014 · Posted 2014-06-09
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeKOD
Date Initiated2014-05-21
Date Terminated2015-11-23
Product Quantity1000 eaches
Reason for Recall
Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Distribution including the states of CA, FL, OH and OK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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