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Recall Observatory FDA recall evidence

Device product

GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap

Z-2785-2016

February 03, 2015

Class II

Product summary

Firm
Allergy Laboratories, Inc.
Event
Event 74851
Status
Terminated
Classification
Class II
Quantity
81,625 vials (3,265 packs)
Official record key
device-enforcement:Z-2785-2016

Official wording

Reason: Potential for glass particles within the vials

Code information: SEV2120414, SEV2120514

Distribution pattern: US Distribution to the state of : NC

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    glass particles