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U.S. Department of Health and Human Services

Class 2 Device Recall RUSCH

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  Class 2 Device Recall RUSCH see related information
Date Initiated by Firm June 30, 2011
Date Posted August 03, 2011
Recall Status1 Terminated 3 on April 29, 2014
Recall Number Z-2943-2011
Recall Event ID 59356
510(K)Number K896729  
Product Classification Catheter, urological - Product Code KOD
Product RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 22 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC.

Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
Code Information Product number: 238500220, Lot numbers: 108305, 140250, 142683, 153802, 276286, 359988, 370083, 375047 and 378586.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Jennifer Thompson
610-478-3131
Manufacturer Reason
for Recall		 Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
FDA Determined
Cause 2		 Other
Action Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990
Quantity in Commerce see line 1.
Distribution Worldwide Distribution and (USA) Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
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 = UNOPLAST A/S
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