ICU Medical Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter
ICU Medical Inc. is recalling 436,716 units of 0.9% Sodium Chloride Injection due to the presence of stainless steel 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (particulate matter in an injection) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but is more severe than a Class III (Low/Moderate).
Plain-English summary
ICU Medical Inc. is recalling 436,716 flexible containers of 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container. The product is identified by NDC# 0409-7983-09 and Lot 61-841-FW, with an expiration date of 01/01/2018. The recall was initiated because of the presence of particulate matter, specifically stainless steel, in the product.
The affected product was distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities should stop using the affected product and contact ICU Medical Inc. for further instructions on how to return or dispose of the recalled items. Consumers should not use the product and should contact their healthcare provider if they have questions regarding its use.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
- Manufacturer
- ICU Medical Inc
- Category
- Drug — IV Fluids
- Affected units
- 436,716
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 (1)
- Lot: 61-841-FW Exp. 01/01/2018
Distribution
Distributed nationwide across the United States.
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