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

Lactated Ringer's Injection, USP flexible container recalled

ICU Medical is recalling Lactated Ringer's Injection, USP flexible 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: 84-603-FW Exp. 01 DEC 2019

Quantity recalled389,808 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-0349-2020
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

LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03

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: 84-603-FW Exp. 01 DEC 2019

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

This product is part of a recall event; the main page for the event is 0.9% Sodium Chloride Injection, USP VisIV Container recalled.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019	CLASS I	0.9% Sodium Chloride Injection, USP VisIV Container recalled	ICU Medical	Particulate Matter	Nationwide

More recalls from ICU Medical

All 663

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled	ICU Medical	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

Other Lactated Ringer's recalls

All 9

Reported	Class	Recall	Company	Reason	Where
27 May 2020Drug	CLASS I	Lactated Ringer's Injection, USP flexible container recalled	ICU Medical	Particulate Matter	Nationwide
25 Feb 2015Drug	CLASS I	Lactated Ringer's and 5% Dextrose Injection USP, flexible containers recalled	Hospira	Mold	Nationwide
3 Dec 2014Drug	CLASS II	Lactated Ringer's and 5% Dextrose Injection recalled by Hospira	Hospira	Sterility	Nationwide
3 Dec 2014Drug	CLASS II	Lactated Ringer's Injection, USP container recalled by Hospira	Hospira	Sterility	Nationwide
24 Apr 2013Drug	CLASS I	Lactated Ringer's and 5% Dextrose Injection, USP flexible container recalled	Hospira	Mold	Nationwide