Magnolia Medical Technologies, Inc. recalls Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access…

Recall date

August 2, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2393-2021

FDA classification

Class II

Brand / firm

Magnolia Medical Technologies, Inc.

Sold / distributed

U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A

Why it was recalled

Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).

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

What was recalled

Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.