Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF U...

FDA Device Recall #Z-1608-2014 — Class II — March 19, 2014

Recall Summary

Recall Number Z-1608-2014
Classification Class II — Moderate risk
Date Initiated March 19, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm RM Temena GmbH
Location Felsberg
Product Type Devices
Quantity 7370 needles

Product Description

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.

Reason for Recall

Ultrasound needles may be defective and leak at the needle hub.

Distribution Pattern

US Distribution including the states of MD and IL.

Lot / Code Information

Lot B3170005, EXP 2018-05-31

Other Recalls from RM Temena GmbH

Recall # Classification Product Date
Z-1609-2014 Class II Ultrasound USB needles, with 30 degree bevel, p... Mar 19, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.