Device product
Aspirated Cyto-Histological Biopsy needle
Z-2490-2021
Product summary
- Firm
- M.D.L. S.r.l.
- Event
- Event 88430
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2750 devices
- Official record key
device-enforcement:Z-2490-2021
Official wording
Reason: Sterility assurance may be compromised.
Code information: Model PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB2010; Lot 1617A Model PB2015; Lots 5216C, 2618B, and 3620D Model PB2020; Lots 5216C and 1618A Model PB2110; Lot 5216C Model PB2115; Lot 5216C Model PB2120; Lot 1617A Model PB2215; Lot 5216C Model PB2220; Lots 5216C, 1618A, 3620D Model PB2225; Lot 2518A
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Sterility assurance may be compromised.