Recall Z-2941-2011 ยท KOD Catheter, Urological
Teleflex Medical
RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 18 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.
| Date | Aug 3, 2011 (initiated Jun 30, 2011) |
| Status | Terminated |
| Reason | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
| Root cause | Other |
| 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 tem |
| Quantity | see line 1. |
| Distribution | Worldwide Distribution and (USA) Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K896729 | NELATON-, FEMALE - OR TIEMANN CATHETER Unoplast A/S, Nov 5, 1990 |