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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84144

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 25, 2019
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
ICU Medical Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-0349-2020
Recall number
D-0349-2020
Initiated
October 25, 2019
Classification
Class I
Status
Terminated
Recalling firm
ICU Medical Inc
Quantity
389,808 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter.

Code information

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

Distribution pattern

Nationwide in the USA.

drug · product 2 of 2

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
Recall number
D-0350-2020
Initiated
October 25, 2019
Classification
Class I
Status
Terminated
Recalling firm
ICU Medical Inc
Quantity
58,464 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter.

Code information

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

Distribution pattern

Nationwide in the USA.