FDA Medical Device Recalls (openFDA)
RM Temena GmbH: 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.
- Recall number
- Z-1608-2014
- Recalling firm
- RM Temena GmbH
- 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.
- Status
- Terminated
- Initiated
- 2014-03-19
- Posted
- 2014-05-12
- Terminated
- 2016-09-19
- Reason
- Ultrasound needles may be defective and leak at the needle hub.
- Root cause
- 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
- 7370 needles
- Distribution
- US Distribution including the states of MD and IL.
- Lot, serial or model codes
- Lot B3170005, EXP 2018-05-31
- 510(k) numbers
- ["K080603"]
- PMA numbers
- not on file
- Product code
- BSP
- Firm FEI
- 3005379387
- Firm city
- Felsberg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28