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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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
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