CLASS II Drug recall · Reported 31 Mar 2021 · FDA Enforcement Report
0.9% Sodium Chloride Irrigation, USP Semi-Rigid recalled by ICU Medical
ICU Medical is recalling 0.9% Sodium Chloride Irrigation, USP Semi-Rigid, distributed nationwide in the US. The recall was initiated on 9 Mar 2021 and the FDA has classified it as Class II.
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-0313-2021
- FDA event ID
- 87484
- Recalling firm
- ICU Medical, Lake Forest, IL
- Brand
- Sodium Chloride
- Manufacturer
- ICU Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2021
- FDA classified
- 25 Mar 2021
- Reported
- 31 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Mar 2021 | Recall initiated by company | |
| 25 Mar 2021 | Classified by FDA | +16 days |
| 31 Mar 2021 | Published in enforcement report | +6 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.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Product as listed by the FDA
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09
Where it was distributed
Distributed Nationwide in the USA to include Puerto Rico
Questions about this recall
Why was it recalled?
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Which lots are affected?
Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
Where was it sold?
Distributed Nationwide in the USA to include Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
All 654| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hotline Fluid Warming Set, single use device recalled by ICU Medical | ICU Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump recalled by ICU Medical | ICU Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Plum Duo Infusion Pump recalled by ICU Medical | ICU Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Plum Duo Precision IV Pump recalled by ICU Medical | ICU Medical | Device Malfunction | Nationwide |
Other Sodium Chloride recalls
All 132| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS II | Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | 0.9% Sodium Chloride Injection, USP Ampules recalled by Huons CoSodium Chloride | Huons | Sterility | Nationwide |