Beacon Tip Technology Catheters By Cook Medical: Recall

Beacon Tip Technology Catheters By Cook Medical: Recall

Beacon Tip Technology Catheters by Cook Medical: Recall

On April 15, 2016, Cook Medical initiated a voluntary recall of 4,146,309 catheters with Beacon Tip technology. Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation, which have resulted in 30 Medical Device Reports to date.

This recall includes all lots of catheters with the Beacon Tip technology.

Cook Medical identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. The preliminary investigation into this matter has identified that environmental conditions, such as storage temperature, humidity, the use of Vaporized Hydrogen Peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. Cook Medical recognizes that there may be other undetermined contributors to this issue and will continue to investigate. Ref. Source 8s.