Z-2490-2021 Class II

Recalled by M.D.L. S.r.l. — Delebio

Recall Details

Product Type
Devices
Report Date
September 29, 2021
Initiation Date
August 5, 2021
Termination Date
N/A
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