Z-1609-2014Class II

Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF...

Name: Z-1609-2014 Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF...
Creator: RM Temena GmbH
Published: 2014-03-19
License: https://open.fda.gov/license/

RM Temena GmbH / initiated 2014-03-19 / Terminated / root cause: manufacturing process

FDA source

RM Temena GmbH began a recall of Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under... on 2014-03-19. FDA classified it as Class II and gives the reason as "Ultrasound needles may be defective and leak at the needle hub". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1609-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-19
Posted: 2014-05-12
Terminated: 2016-09-19
Recalling firm: RM Temena GmbH
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
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Reason for recall: Ultrasound needles may be defective and leak at the needle hub.
Root cause tag: manufacturing process
FDA 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 in commerce: 7370 needles
Distribution: US Distribution including the states of MD and IL.
Product codes and lots: Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1609-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1608-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-12
Z-1609-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-12

Product code BSP

K080603Class IIHybrid Nerve Location Needle Coated and UncoatedTe ME NA Sas / cleared 2008-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)