U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Ultrasound needles may be defective and leak at the needle hub.
조치
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