CLASS I Drug recall · Reported 13 Nov 2019 · FDA Enforcement Report

0.9% Sodium Chloride Injection, USP VisIV Container recalled

ICU Medical is recalling 0.9% Sodium Chloride Injection, USP VisIV Container, distributed nationwide in the US. The recall was initiated on 25 Oct 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot: 95-101-C6 Exp. 01 MAY 2020

Quantity recalled58,464 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0350-2020
FDA event ID: 84144
Recalling firm: ICU Medical, Lake Forest, IL
Classification: Class I
Status: Terminated
Recall initiated: 25 Oct 2019
FDA classified: 15 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

25 Oct 2019	Recall initiated by company
13 Nov 2019	Published in enforcement report	+19 days
15 Nov 2019	Classified by FDA	+2 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter.

Product as listed by the FDA

0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25

Where it was distributed

Nationwide in the USA.

Nationwide

Questions about this recall

Why was it recalled?

Presence of Particulate Matter.

Which lots are affected?

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

Where was it sold?

Nationwide in the USA.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84144

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019	CLASS I	Lactated Ringer's Injection, USP flexible container recalled	ICU Medical	Particulate Matter	Nationwide

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Other Sodium Chloride recalls

All 133

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride	B Braun Medical	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
13 May 2026Drug	CLASS I	Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
29 Apr 2026Drug	CLASS II	Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation	B Braun Medical	Sterility	Nationwide