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Recall Observatory FDA recall evidence

Device product

Luer Lock Set - Catalog # MPC-125, for IV administration sets.

Z-2354-2019

June 10, 2019

Class II

Product summary

Firm
Molded Products Inc
Event
Event 83330
Status
Terminated
Classification
Class II
Quantity
130,000 sets
Official record key
device-enforcement:Z-2354-2019

Official wording

Reason: Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150.

Code information: LOT NUMBER: 20266 UDI # +B144MPC1251/$$52232420266N Expiration Date 11/20/2022

Distribution pattern: Distribution US nationwide.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeling