CLASS I Drug recall · Reported 27 May 2020 · 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 8 May 2020 and the FDA has classified it as Class I.
Check your package
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-1270-2020
- FDA event ID
- 85625
- Recalling firm
- ICU Medical, Lake Forest, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 May 2020
- FDA classified
- 19 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 8 May 2020 | Recall initiated by company | |
| 19 May 2020 | Classified by FDA | +11 days |
| 27 May 2020 | Published in enforcement report | +8 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: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Product as listed by the FDA
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Which lots are affected?
Lot #: 07-514-FW Exp. 01-JUL-2021
Where was it sold?
Nationwide within the United States
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.
More recalls from ICU Medical
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| Device | CLASS II | CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled | ICU Medical | Packaging Defects | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Non-Dedicated Gravity Administration Sets with drip chambers recalled | ICU Medical | Foreign Material | Nationwide |
| Device | 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 |
|---|---|---|---|---|---|
| Drug | CLASS I | Lactated Ringer's Injection, USP flexible container recalled | ICU Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's and 5% Dextrose Injection USP, flexible containers recalled | Hospira | Mold | Nationwide |
| Drug | CLASS II | Lactated Ringer's and 5% Dextrose Injection recalled by Hospira | Hospira | Sterility | Nationwide |
| Drug | CLASS II | Lactated Ringer's Injection, USP container recalled by Hospira | Hospira | Sterility | Nationwide |
| Drug | CLASS I | Lactated Ringer's and 5% Dextrose Injection, USP flexible container recalled | Hospira | Mold | Nationwide |