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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasound needles

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 Class 2 Recall
Ultrasound needles
see related information
Date Posted May 12, 2014
Recall Status1 Open
Recall Number Z-1608-2014
Recall Event ID 68026
Premarket Notification
510(K) Number
K080603 
Product Classification Needle, Conduction, Anesthetic (W/Wo Introducer) - Product Code BSP
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.
Code Information Lot B3170005, EXP 2018-05-31
Recalling Firm/
Manufacturer
RM Temena GmbH
Mittelhoefer Str. 1
D-34587
Felsberg
Manufacturer Reason
for Recall
Ultrasound needles may be defective and leak at the needle hub.
FDA Determined
Cause 2
DESIGN: 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 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 7370 needles
Distribution 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) Database 510(K)s with Product Code = BSP and Original Applicant = TE ME NA SAS
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