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Recall Observatory FDA recall evidence

Device product

Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209

Z-2365-2015

July 09, 2015

Class II

Product summary

Firm
Cadence Inc.
Event
Event 71674
Status
Terminated
Classification
Class II
Quantity
1665 units
Official record key
device-enforcement:Z-2365-2015

Official wording

Reason: Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.

Code information: Packged Lots: Catalog Number 5208: 79895-01, 80044-02, 82350-01, W006510/1; Catalog Number 5209: 71880-01, 76434-01, 76461-01, 76461-02, 76461-03, 76461-04, 76461-05, 76461-06, 76461-07, 76461-08, 79748-01, 80044-03, W001711/1, W002337/1, W002886/1

Distribution pattern: Nationwide Foreign Canada, Denmark. Italy

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.