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Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The ...

FDA Recall #Z-0897-2015 — Class II — November 21, 2014

Recall #Z-0897-2015 Date: November 21, 2014 Classification: Class II Status: Completed

Product Description

Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

Reason for Recall

Needle is not captured in the needle safety sheath in specific lots.

Recalling Firm

Smiths Medical ASD, Inc. — Keene, NH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

334,000

Distribution

US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV

Code Information

Lot Numbers: 2731779, 2763138, 2771516, 2771517

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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