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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 02, 2011
Date Posted June 27, 2011
Recall Status1 Terminated 3 on April 05, 2013
Recall Number Z-2672-2011
Recall Event ID 58966
Product Classification Bag, urine collection, leg, for external use, sterile - Product Code FAQ
Product RUSCH Urinary Drainage Bag, 2000 ml

Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
Code Information Catalogue number: 390060, Lot number: 20100515 & 20100501; Catalogue number: 452919, Lot number: 20100405.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Robert Phillips
919-433-4829
Manufacturer Reason
for Recall		 Sterile integrity cannot be guaranteed.
FDA Determined
Cause 2		 Other
Action Teleflex Medical sent an " URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 2, 2011. The letter identified the product, the problem and the actions needed to be taken. The customers were instructed to immediately discontinue distribution, quarantine any affected products, communicate this recall to any of their customers using the provided customer letter, and complete and fax the enclosed Recall Acknowledgement Form to Customer Service at 1-866-804-9881. Once the fax is received instructions for product return will be provided to customers. In the event that an alternative approach is needed, customers are instructed to contact Teleflex Medical Customer Service at 1- 866-246-6990. For further questions contact your sales representative or Customer Service at 1-866-246-6990. The recall was expanded and an additional letter was sent out on July 20, 2011 to the affected consignees with the above instructions. *****RECALL EXPANDED***** Product 2. Teleflex sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated July 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. On July 19, 2011 this recall was expanded to include additional product. Please see above strategy information for details
Quantity in Commerce 14,488 eaches
Distribution Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico.
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.
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