M.D.L. S.r.l. Recall 88430
Description: Mammary Nodules Localization
M.D.L. S.r.l. Recall 88430 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2491-2021 |
Event ID | 88430 |
Event Description | Mammary Nodules Localization |
Product Type | Devices |
Distribution | Nationwide |
Quantity | 320 units |
Recall Reason | Sterility assurance may be compromised. |
Device Classification | 20210929 |
Device Code Info | Model 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 Date | 20210920 |
Recall Initiation Date | 20210805 |
Recalling Firm | M.D.L. S.r.l. |
Initial Notification | Letter |
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