Sodium Chloride Irrigation (ICU Medical) – particulate matter (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
ICU Medical Inc
Lot Codes / Batch Numbers
Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
Products Sold
Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
ICU Medical Inc is recalling 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medica due to Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026