Exact FDA event identifier

Event 91113

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

Event summary

Timeline bucket: November 09, 2022
Product types: Drug
Classifications: Class II
Statuses: Ongoing
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

0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

D-0062-2023

Recall number: D-0062-2023
Initiated: November 09, 2022
Classification: Class II
Status: Ongoing
Recalling firm: ICU Medical Inc
Quantity: 137,120 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

Code information

Lot: 5829936, Exp. MAR 31 2024

Distribution pattern

Nationwide in the USA