DUBLIN, Ohio, Feb. 6 (UPI) -- Cardinal Health said Tuesday it has struck an agreement with the U.S. Food and Drug Administration to resume sales of its Alaris SE Infusion Pump.
The deal calls for the company to submit a plan to the FDA outlining corrections for pumps currently in use by customers, submit a remediation plan for the seized pumps, and engage an independent expert to inspect and certify the facilities where the Alaris pumps are manufactured.
The action plan must be approved by the FDA before it can be implemented, Cardinal said, and is also subject to approval by the U.S. District Court for the Southern District of California.
"We have worked very closely with the FDA since initiating a voluntary field corrective action for the product last year, and are pleased to have now reached this agreement outlining the steps we'll take to resume manufacturing and sale of the Alaris SE pumps," said Dave Schlotterbeck, chief executive officer of pharmaceutical and medical products for Cardinal Health.
The pumps were the target of an FDA seizure action after a defect was found on about 1,300 of the devices that put patients at risk for over-infusion, Cardinal said. The company suspended production, sales and repairs of the pumps last August.
