Mallinckrodt—RAPLIXA Delivery Kits containing RaplixaSpray Devices: May Not Meet 510(k) Premarket Notification Claims; Manufacturer Initiates Recall
December 13, 2017 | Strategic Insights for Health System
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In a December 4, 2017, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Mallinckrodt states that the filter in the insufflation filter assembly of the RaplixaSpray devices in the above kits may not meet claims made in the device's 510(k) premarket notification. The firm states that it has received no reports of adverse events or patient concerns associated with the problem and that any risk to patients is remote. The recall is being conducted according to FDA regulations and does not affect the 1-gram vial of the RAPLIXA fibrin sealant for topical use product or the associated regulator. The manufacturer has not confirmed the...