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Recall Observatory FDA recall evidence

Device product

Terumo Needle, 18G x 1", Product Code NN1825R

Z-2004-2019

February 08, 2019

Class II

Product summary

Firm
Terumo Medical Corporation
Event
Event 82212
Status
Terminated
Classification
Class II
Quantity
810,000
Official record key
device-enforcement:Z-2004-2019

Official wording

Reason: There is a potential for a loss of package integrity that may compromise the sterility of the product.

Code information: Lot Numbers 180714C, 180723C

Distribution pattern: The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    package integrity that may compromise
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    package integrity that may compromise the sterility