RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 12 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.
This recall has been terminated (originally issued August 3, 2011).
- Company
- Teleflex Medical
- Recall Initiated
- June 30, 2011
- Posted
- August 3, 2011
- Terminated
- April 29, 2014
- Recall Number
- Z-2938-2011
- Quantity
- see line 1.
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Distribution
Worldwide Distribution and (USA) Nationwide Distribution.
Lot / Code Info
Product number: 238500120, Lot numbers: 06082, 34209, 103023, 105425, 106243, 118052, 119399, 119400, 121547, 121548, 122736, 127590, 127591, 132131, 134609, 135860, 138375, 140667, 141201, 142559, 142560, 142672, 310423, 317993, 322169, 335503, 338375, 340209, 342030, 342031, 350046, 359265, 359984, 380069, 380178, 380261, 381718, 381719, 384488 and 841934.
Root Cause
Other
Action Taken
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