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U.S. Department of Health and Human Services

Class 2 Device Recall Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device

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  Class 2 Device Recall Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device see related information
Date Initiated by Firm June 27, 2011
Date Posted July 15, 2011
Recall Status1 Terminated 3 on March 20, 2012
Recall Number Z-2831-2011
Recall Event ID 59184
Product Classification Sheath, Corrugated rubber, for nonindwelling catheter - Product Code NNY
Product Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical.

Used for urine collection.
Code Information Catalog number: A1300VA, Lot number: 02E1002552   Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Robert Phillips
610-378-0131
Manufacturer Reason
for Recall		 The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.
FDA Determined
Cause 2		 Other
Action Teleflex Medical sent an "Urgent Medical Device Recall Notification" dated June 27, 2011 to all affected customers. The firm provided recommendations including all affected product be discontinued and quarantined. A Recall Acknowledgement Form was provided to be completed and returned. If the product was further distributed, they were urged to contact their customers and communicate the recall. For additional information please contact Customer Service at 866-246-6990 or your local sales representative.
Quantity in Commerce 6880 units (total for both products)
Distribution Nationwide Distribution (USA) including the states of FL, GA, OH and SC.
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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