Z-2490-2021 Class II Terminated
FDA device recall Z-2490-2021 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: 2750 devices.
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
- 2750 devices
Product Description
Aspirated Cyto-Histological Biopsy needle
Reason for Recall
Sterility assurance may be compromised.
Distribution Pattern
Nationwide
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