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
FDA Recall Z-1609-2014 · Posted 2014-05-12
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Recalling FirmRM Temena GmbH
Recall StatusTerminated
Product CodeBSP
Date Initiated2014-03-19
Date Terminated2016-09-19
Product Quantity7370 needles
Reason for Recall
Ultrasound needles may be defective and leak at the needle hub.
Firm 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
Root Cause
Process design
Distribution Pattern
US Distribution including the states of MD and IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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