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RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile… recallZ-1732-2014 · Teleflex Medical · initiated May 21, 2014

Class II Terminated All recalls posted in June 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product was packaged with a straight catheter rather than the correct coude (curved) catheter.

FDA root cause category: Mixed-up of materials/components

What the company is doing

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.

Recall details

Recall number
Z-1732-2014
Recall class
Class II
Status
Terminated
Initiated by the company
May 21, 2014
Posted by the FDA
Jun 9, 2014
Recalling firm
Teleflex Medical
Quantity
1000 eaches
Product code
KOD
FDA submissions
K000070
Distribution
US Distribution including the states of CA, FL, OH and OK.

Product description

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.

Code information (models, lots, serial numbers)

Product Code: ECK103, Lot number: 02A1402484

Other devices under the same FDA submission

4 devices cleared under K000070 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page