||May 12, 2014
|Recall Event ID
Needle, conduction, anesthetic (w/wo introducer) -
||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
||Lot B3070012 EXP 2018-02-28
Lot B3250001 EXP 2018-06-30
Lot B3250026 EXP 2018-06-30
RM Temena GmbH
Mittelhoefer Str. 1
|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.
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
|Quantity in Commerce
||US Distribution including the states of MD and IL.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = BSP and Original Applicant = TE ME NA SAS