Product Safety Recalls

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M.D.L. S.r.l. Recall 88430

Description: Mammary Nodules Localization

M.D.L. S.r.l. Recall 88430 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2491-2021
Event ID88430
Event DescriptionMammary Nodules Localization
Product TypeDevices
DistributionNationwide
Quantity320 units
Recall ReasonSterility assurance may be compromised.
Device Classification20210929
Device Code InfoModel Number PN2010, Lots: 3620D Model Number PN2012, Lots: 1317 Model Number PN2015, Lots: 3620D Model Number PNA2005, Lots: 5216C Model Number PNA2010, Lots: 3620D Model Number PNA2015, Lots: 3620D Model Number PNAX2005, Lots: 5216C Model Number PNS2010, Lots: 3620D Model Number PNS2015, Lots: 3620D Model Number PNX2010, Lots: 0817A Model Number PR2005, Lots: 5216C, 4920B Model Number PR2007, Lots: 5216C Model Number PR2010, Lots: 3620D Model Number PR2015, Lots: 3620D
Center Classification Date20210920
Recall Initiation Date20210805
Recalling FirmM.D.L. S.r.l.
Initial Notification Letter
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