Recall Z-0509-2021— Janus Trade Group

Name: FDA recall Z-0509-2021
Creator: U.S. Food and Drug Administration
Published: 2020-03-23

Class II · Terminated

Class II FDA medical device recall by Janus Trade Group, initiated 2020-03-23, terminated 2021-05-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG..

Recalling firm: Janus Trade Group
Classification: Class II
Status: Terminated
Initiated: 2020-03-23
Terminated: 2021-05-20
Firm location: Eatontown, NJ, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.