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Recall Observatory FDA recall evidence

Drug product

LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03

D-0349-2020

October 25, 2019

Class I

Product summary

Firm
ICU Medical Inc
Event
Event 84144
Status
Terminated
Classification
Class I
Quantity
389,808 bags
Official record key
drug-enforcement:D-0349-2020

Official wording

Reason: Presence of Particulate Matter.

Code information: Lot: 84-603-FW Exp. 01 DEC 2019

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter