Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles
FDA device recall Z-1609-2014 · posted 2014-05-12 · Terminated
Recall details
- Recalling firm
- RM Temena GmbH
- Reason for recall
- Ultrasound needles may be defective and leak at the needle hub.
- Action taken
- 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
- Status
- Terminated
- Product code
- BSP
- Quantity affected
- 7370 needles
- Distribution
- US Distribution including the states of MD and IL.
- Date initiated
- 2014-03-19
- Date posted
- 2014-05-12
- Date terminated
- 2016-09-19
- Location
- Felsberg, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED (K080603) | Te ME NA Sas | 2008-08-05 |