Medical device recalls Moderate risk

Magnolia Medical Technologies, Inc. recalls The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System…

Recall date
November 2, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0318-2022
FDA classification
Class II
Brand / firm
Magnolia Medical Technologies, Inc.
Sold / distributed
U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.

Why it was recalled

Due to an uptick of complaints associated with premature needle retraction of blood collection system.

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

What was recalled

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

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