Information on Unauthorized Distribution of Introcan Safety® Catheters
On December 2, 2020, B. Braun was made aware of a recall, by the company Janus Trade Group, of eight Introcan Safety Catheter product codes not authorized by the FDA to be sold in the United States (See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=184307). The recalled products were distributed in the United States by Janus Trade Group without B. Braun’s knowledge or authorization. The FDA’s recall announcement does not indicate any concern regarding the clinical performance of the Introcan Safety Catheter products. B. Braun intends to pursue all actions necessary to cause Janus Trade Group to cease and desist from distributing unauthorized B. Braun products. We are committed to the safe distribution and use of our products. We ask customers who purchase Introcan Safety Catheters to visit https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=184307 to review affected product codes and lots.
Please reach out to B. Braun Customer Service at 1-800-227-2862 for further information.