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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 RUSCHsee related information
Date Initiated by FirmJune 30, 2011
Date PostedAugust 03, 2011
Recall Status1 Terminated 3 on April 29, 2014
Recall NumberZ-2932-2011
Recall Event ID 59356
510(K)NumberK896729 
Product Classification Catheter, urological - Product Code KOD
ProductRUSCH, GB: Female Catheter, All Purpose PVC, 08 Fr. 18 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: 238300080, Lot Numbers: 082827-1, 120007, 122274, 122275, 123171, 124446, 129582, 130627, 142572, 318007, 322167, 335514,338383, 340211, 342044, 350053, 350054, 350055, 359272, 359989 and 405523.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information ContactJennifer 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
ActionTeleflex 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 Commerce14,378,890 units
DistributionWorldwide Distribution and (USA) Nationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KOD
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