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U.S. Department of Health and Human Services

Class 2 Device Recall RUSCH Easy Cath

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 Class 2 Recall
RUSCH Easy Cath
see related information
Date Posted June 09, 2014
Recall Status1 Open
Recall Number Z-1732-2014
Recall Event ID 68350
Premarket Notification
510(K) Number
K000070 
Product Classification Catheter, Urological - Product Code KOD
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.
Code Information Product Code: ECK103, Lot number: 02A1402484
Recalling Firm/
Manufacturer
Teleflex Medical
2917 Weck Dr.
Research Triangle Park, North Carolina 27709
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall
Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KOD and Original Applicant = RUSCH INTL.
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