CareFusion (NYSE:CFN) issued a pair of recalls involving 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 San Diego-based device maker recalled certain lots of its AirLife infant breathing circuits after receiving reports that the Y-shaped adapters may be prone to cracking, creating leaks in the closed ventilation system.
One such incident reported to the FDA’s MAUDE adverse event report database in April noted that the Y-adapters had cracked in 5 different cases, but there had been no known harm to patients.
The devices have an alarm system intended to warn health providers when the patient isn’t getting sufficient ventilation. CareFusion has switched to a stronger component for its newer breathing circuit devices, the company told Reuters.
The FDA hit the recall with Class I status, associated with "a reasonable probability of serious adverse health consequences or death associated with use of the defective units," according to a press release.
"Since the recall was initiated in May, nearly half of the affected customers and distributors have completed the remediation process," according to the report.
CareFusion late last month issued an unrelated recall affecting certain lots of its Alaris infusion pumps after the company identified a potential problem with its power supply board.
"In certain cases, a component on the PC unit power supply board can malfunction, which causes an error code and triggers an audible alarm and visual error message on the PC unit screen," according to a regulatory filing. "The company is working with its customers to repair the power supply board."
"Based on current estimates for this work and adjustments to the company’s reserve associated with other product recalls, the company expects to increase its total recall reserve by approximately $7 million for the quarter and fiscal year ended June 30, 2012," according to the report.
CareFusion’s had a tough go the last few weeks. The company took another hit last month when Google’s web services put a block on their respiratory software delivery website after a scan of the site found viruses and other malicious programs that may have been transmitted to other users’ computers.
CFN shares were flat at $25.77 as of about 11:45 a.m. today.
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