Date Initiated by Firm |
May 21, 2014 |
Date Posted |
June 09, 2014 |
Recall Status1 |
Terminated 3 on November 23, 2015 |
Recall Number |
Z-1732-2014 |
Recall Event ID |
68350 |
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 NC 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 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = KOD and Original Applicant = RUSCH INTL.
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