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Recall Observatory FDA recall evidence

Device product

3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only

Z-0318-2021

June 24, 2019

Class II

Product summary

Firm
OriGen Biomedical, Inc.
Event
Event 85124
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0318-2021

Official wording

Reason: The firm has become aware that they have distributed product that was expired.

Code information: Lot # 042417-5045

Distribution pattern: US: TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm has become aware that they have distributed product that was expired.