Recall Z-1609-2014 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
RM Temena GmbH
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
| Date | May 12, 2014 (initiated Mar 19, 2014) |
| Status | Terminated |
| Reason | Ultrasound needles may be defective and leak at the needle hub. |
| Root cause | Process design |
| Action | Temena sent an Urgent Recall letter dated March 24, 2014, to the affected customers. The letter identified the product the problem and the action needed to be taken by the customer. IMPORTANT INSTRUCTIONS: 1. Ensure that the devices questions will not be applied to humans. 2. Opened packages shall not be used any more. 3. Please send us back the request of products (including opened packages) 4. Inform your distribution partners / further resellers about this recall to achieve a 100% recall of all unused products. 5.Please add a copy of our invoice / respectively of our delivery notes, to car |
| Quantity | 7370 needles |
| Distribution | US Distribution including the states of MD and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080603 | HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED Te ME NA Sas, Aug 5, 2008 |