Recall Z-1608-2014
RM Temena GmbH · initiated March 19, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot B3170005, EXP 2018-05-31
Reason for recall
Ultrasound needles may be defective and leak at the needle hub.
FDA-determined cause: Process design
Action taken
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
Details
- Recall number
- Z-1608-2014
- Initiated
- March 19, 2014
- Posted by FDA
- May 12, 2014
- Terminated
- September 19, 2016
- Product code
- BSP – Needle, Conduction, Anesthetic (W/Wo Introducer)
- Quantity
- 7370 needles
- Distribution
- US Distribution including the states of MD and IL.
- Recalling firm
- RM Temena GmbH, Felsberg
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1609-2014 Class II | Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box…Ultrasound needles may be defective and leak at the needle hub. | 03/19/2014Terminated |