Janus Trade Group recalls B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890…

Recall date

March 23, 2020

Source

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

Recall number

Z-0509-2021

FDA classification

Class II

Brand / firm

Janus Trade Group

Sold / distributed

US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.

Why it was recalled

Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.

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

What was recalled

B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01