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Recall Observatory FDA recall evidence

Drug product

0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25

D-0350-2020

October 25, 2019

Class I

Product summary

Firm
ICU Medical Inc
Event
Event 84144
Status
Terminated
Classification
Class I
Quantity
58,464 bags
Official record key
drug-enforcement:D-0350-2020

Official wording

Reason: Presence of Particulate Matter.

Code information: Lot: 95-101-C6 Exp. 01 MAY 2020

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter