Recall events
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Event 80213
Event summary
Timeline bucket May 31, 2018
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
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
5 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 5
0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
D-0881-2018
Recall number D-0881-2018
Initiated May 31, 2018
Classification Class II
Status Terminated
Quantity 88960 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 potential to leak.
Code information Lot #: 85-023-JT, Exp 7/1/2019
Distribution pattern Nationwide and Canada
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10068]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 5
0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
D-0882-2018
Recall number D-0882-2018
Initiated May 31, 2018
Classification Class II
Status Terminated
Quantity 941496 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 potential to leak.
Code information Lot #: 85-018-JT, 85-031-JT, Exp. 01/01/2020
Distribution pattern Nationwide and Canada
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10381]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 5
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
D-0883-2018
Recall number D-0883-2018
Initiated May 31, 2018
Classification Class II
Status Terminated
Quantity 525984 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 potential to leak.
Code information Lot #: 85-016-JT, Exp 01/01/2020
Distribution pattern Nationwide and Canada
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10059]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 5
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
D-0884-2018
Recall number D-0884-2018
Initiated May 31, 2018
Classification Class II
Status Terminated
Quantity 1247200 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 potential to leak.
Code information Lot #: 85-021-JT, Exp 01/012020; 86-001-JT, Exp 02/01/2020
Distribution pattern Nationwide and Canada
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10065]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 5
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
D-0885-2018
Recall number D-0885-2018
Initiated May 31, 2018
Classification Class II
Status Terminated
Quantity 267288 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 potential to leak.
Code information Lot #: 86-033-JT, Exp 08/01/2019
Distribution pattern Nationwide and Canada
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10188]
FDA event record
· Exact recall-number query on openFDA
