Information on Unauthorized Distribution of Introcan Safety® Catheters
On January 29, 2021, B. Braun was made aware of a recall, by the company Braxton Medical Corporation, of 16 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=183721). The recalled products were distributed in the United States by Braxton Medical Corporation 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 Braxton Medical Corporation 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=183721 to review affected product codes and lots.
Please reach out to B. Braun Customer Service at 1-800-227-2862 for further information.