CareFusion (NYSE:CFN) lost some points on Wall Street after the FDA slapped its latest infusion pump recall with Class I status, reserved for the most potentially dangerous device defects.
CareFusion announced the 3rd recall in as many months, the 2nd affecting infusion pumps, after discovering issues with the keypad overlay on Alaris model 8100 infusion pump module door.
"When the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm," according to a letter sent to customers. "Termination of infusion could result in serious injury or death."
CareFusion is asking customers to inspect their pump modules and notify the company of any signs of overlay separation, after which CareFusion will schedule time to replace the component.
Earlier this year the San Diego-based device maker recalled certain lots of its AirLife infant breathing circuits and certain Alaris infusion pumps, in the process adding $7 million to its “recall reserve” for the 2nd quarter.
The latest recall, announced yesterday, preceded a 2% drop in CFN shares. CFN stock opened at $26.89 yesterday morning and was trading around $26.41 as of about 3 p.m. today.
