Agency classClass IIOur severity:Severe FDA (Drugs)·D-0313-2021·Announced 2021-03-31

ICU Medical Recalls Sodium Chloride Irrigation Due to Particulate Matter

ICU Medical is recalling 425,628 bottles of 0.9% Sodium Chloride Irrigation due to the presence of particulate matter.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) according to the rubric for agency classifications.

Plain-English summary

ICU Medical Inc. is recalling 425,628 bottles of 0.9% Sodium Chloride Irrigation, USP, 1000 mL Semi-Rigid Bottle. The product is a prescription-only medication manufactured for ICU Medical, Inc., in Lake Forest, Illinois. The recall is being conducted because of the presence of particulate matter.

The affected lots are 16-808-4B, 16-803-4B, and 16-809-4B, all with an expiration date of April 01, 2023. The product was distributed nationwide in the USA, including Puerto Rico. The recall was initiated after one confirmed customer report of particulate matter within two semi-rigid bottles, which was identified prior to use.

Healthcare providers and consumers should stop using the affected product and contact ICU Medical for further instructions or a replacement.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: ICU Medical Inc
Category: Drug — Irrigation
Hazard: particulate-matter
Affected units: 425,628

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Lots: 16-808-4B
16-803-4B
16-809-4B
Exp. April 01
2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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