Drug recall: LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-795

FDA enforcement event 84144 · Class I · initiated 25 Oct 2019 · status Terminated · terminated 20 Jan 2022

DrugVoluntary: Firm initiated2 product recordsLake Forest, IL

ICU Medical Inc (Lake Forest, IL) initiated this drug recall on 25 Oct 2019; FDA lists 2 product records under event 84144, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 10% of the 362 drug enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 20 Jan 2022. Initiation: voluntary: firm initiated. ICU Medical Inc has 75 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

ICU Medical Inc, Lake Forest, IL.

Reason for recall

"Presence of Particulate Matter."

Distribution

"Nationwide in the USA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0349-2020	LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03	389,808 bags	Class I	Terminated	13 Nov 2019
D-0350-2020	0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25	58,464 bags	Class I	Terminated	13 Nov 2019

Context

10%of 2019 drug events are Class I362 events that year

2product records in this eventfirm median: 2

75events on this register for the firm

Other enforcement events for ICU Medical Inc

Initiated	Product (first record)	Type	Class	Records
20 Aug 2026	CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Code	Device	Class II	1
24 Jun 2026	Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the p	Device	Class II	1
10 Jun 2026	ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump	Device	Class II	2
12 May 2026	Plum administration sets	Device	Class II	8
29 Apr 2026	Plum Solo Precision IV Pump, 40001-0401	Device	Class II	3
24 Mar 2026	Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock	Device	Class II	1
19 Dec 2025	Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000	Device	Class II	1
19 Dec 2025	Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG	Device	Class II	2
15 Dec 2025	Plum Duo Infusion System, List Number 40002-04-01	Device	Class II	1
15 Dec 2025	ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)	Device	Class II	3

All 75 events for ICU Medical Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Presence of Particulate Matter."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide in the USA."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 20 Jan 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.