Exact FDA event identifier

Event 85625

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 08, 2020
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

D-1270-2020

Recall number: D-1270-2020
Initiated: May 08, 2020
Classification: Class I
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 93,648 flexible container

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: confirmed customer complaint for the presence of particulate matter identified as iron oxide.

Code information

Lot #: 07-514-FW Exp. 01-JUL-2021

Distribution pattern

Nationwide within the United States