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Recall Observatory FDA recall evidence

Device product

Aspirated Cyto-Histological Biopsy needle

Z-2490-2021

August 05, 2021

Class II

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

    reason.no_named_rule · v1.0.0

    Sterility assurance may be compromised.