Medical device recalls Moderate risk

Smiths Medical ASD Inc. recalls Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposab…

Recall date
February 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1733-2019
FDA classification
Class II
Brand / firm
Smiths Medical ASD Inc.
Sold / distributed
US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA.

Why it was recalled

Incorrect needle length and gage.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

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