RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 14 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.
FDA Recall Z-2939-2011 · Posted 2011-08-03
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeKOD
Date Initiated2011-06-30
Date Terminated2014-04-29
Product Quantitysee line 1.
Reason for Recall
Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Firm 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
Root Cause
Other
Distribution Pattern
Worldwide Distribution and (USA) Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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