Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
Recall
- Recall Number
- Z-1608-2014
- Event Number
- 68026
- Firm
- RM Temena GmbH Mittelhoefer Str. 1 D-34587 Felsberg Germany
- FEI Number
- 3005379387
- Product Code
- BSP
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- March 19, 2014
- Posted
- May 12, 2014
- Terminated
- September 19, 2016
Description
Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
Ultrasound needles may be defective and leak at the needle hub.
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 carry out a cost reimbursement or receive compensation delivery or a credit note. 6. Please use attached form to answer Temena SAS. Further questions please call: +33(0)1.30.86.05.30 We sincerely apologize for the inconvenience this may have caused by this product recall we thank you in advance for your support
US Distribution including the states of MD and IL.
7370 needles