Z-2491-2021 Class II Terminated
FDA device recall Z-2491-2021 was initiated by M.D.L. S.r.l. on August 5, 2021 and is designated Class II. Reason for recall: Sterility assurance may be compromised. The recall status is terminated (terminated May 4, 2026). Affected quantity: 320 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- August 5, 2021
- Termination Date
- May 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320 units
Product Description
Mammary Nodules Localization
Reason for Recall
Sterility assurance may be compromised.
Distribution Pattern
Nationwide
Code Information
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