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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87484

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

Open FDA event record

Event summary

Timeline bucket
March 09, 2021
Product types
Drug
Classifications
Class II
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

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

0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09

D-0313-2021
Recall number
D-0313-2021
Initiated
March 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical Inc
Quantity
425,628 bottles

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.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use

Code information

Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023

Distribution pattern

Distributed Nationwide in the USA to include Puerto Rico