Teleflex Recalls Pediatric Anesthesia Breathing Circuits Due to Cracking
Teleflex Medical is recalling its Hudson RCI Pediatric Anesthesia Breathing Circuits because the ends of the devices might crack or break during use. The problem could result in delay of treatment, breathing difficulties or death, according to a recall notice posted to the FDA’s website.
The Durham, N.C., devicemaker sent an urgent recall letter to customers on Sept. 8, instructing them to immediately discontinue use and quarantine any affected products, halt distribution and remove the devices from inventory. Customers were asked to return a recall acknowledgement form and notify any of their customers who may have received the device through redistribution.
The affected products were manufactured between March 2013 and July 2014 and distributed between June 2013 and May of this year.
The Hudson RCI circuits are used in hospitals to care for pediatric patients, delivering a mixture of anesthesia and/or other gases from a mechanical ventilator to a patient.
Healthcare providers should report adverse events or side effects related to use of the products to the FDA's MedWatch program, Teleflex said. — Kellen Owings
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