Angiodynamics, Inc. recalls BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagno…

Recall date

May 4, 2020

Source

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

Recall number

Z-2396-2020

FDA classification

Class II

Brand / firm

Angiodynamics, Inc.

Sold / distributed

US Nationwide distribution.

Why it was recalled

Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.

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

What was recalled

BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721 H96560M0367081 H96560M05019121 H96560M05019131 H96560M1220291 H96560M1303161 H96560M1303181 H96560M1318211 H96560M1408911 H96560M1429481 H96560M1803431 H96560M18157131 H96560M2208531 H96560M2208541 H96560M2500981 H96560M611025111 H96560M611052811 H96560M611056011 H96560M611095811 H965PKM1387818S1 H965PKM1404211S1 H965PKM1635214S1 H965PKM220533S1 H965PKM220853S1 H965PKM220855S1 H965PKM61095322S1 H965PKM61102511S1 Cat. No. 60M012571 60M013354 60M035472 60M036708 60M0501912 60M0501913 60M122029 60M130316 60M130318 60M131821 60M140891 60M142948 60M180343 60M1815713 60M220853 60M220854 60M250098 60M61102511 60M61105281 60M61105601 60M61109581 PKM1387818S PKM1404211S PKM1635214S PKM220533S PKM220853S PKM220855S PKM61095322S PKM61102511S