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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasound needles

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  Class 2 Device Recall Ultrasound needles see related information
Date Initiated by Firm March 19, 2014
Date Posted May 12, 2014
Recall Status1 Terminated 3 on September 19, 2016
Recall Number Z-1609-2014
Recall Event ID 68026
510(K)Number K080603  
Product Classification Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
Product 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
Code Information Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30  
Recalling Firm/
Manufacturer		 RM Temena GmbH
Mittelhoefer Str. 1
D-34587
Felsberg Germany
Manufacturer Reason
for Recall		 Ultrasound needles may be defective and leak at the needle hub.
FDA Determined
Cause 2		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSP and Original Applicant = TE ME NA SAS
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