Bloomington-based Cook Medical has issued a voluntary recall of more than four million catheters with Beacon Tip technology. Cook says the catheters have been found to have degradation of the tip, which has led to tip fracture and/or separation.
Cook says it has notified customers and distributors by recall notification letters, which request that all potentially affected units be quarantined and returned. The company says a preliminary investigation identified that environmental conditions may have contributed to the degradation.
The company says the FDA and other regulatory agencies have been notified. You can find a list of affected units by clicking here.
Consumers with questions or concerns can contact Cook Medical Customer Relations at 1-800-457-4500, between 7:30 a.m. and 5:00 p.m. Eastern Time Monday through Friday.