ICU Medical Recalls 0.45% Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
ICU Medical Inc. is voluntarily recalling 88,960 bags of 0.45% Sodium Chloride Injection, USP, 100 mL. The product is identified by NDC 0409-7730-37, Lot # 85-023-JT, and an expiration date of 7/1/2019. The recall is being conducted because there is a lack of assurance of sterility, as the bags have the potential to leak.
The affected product was distributed nationwide and in Canada. This is a prescription-only medication intended for intravenous use. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the distributor or the recalling firm, ICU Medical Inc.
The recalled product
- Product
- 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
- Manufacturer
- ICU Medical Inc
- Category
- Drug — IV Fluids
- Affected units
- 88,960
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 (2)
- Lot #: 85-023-JT
- Exp 7/1/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by ICU Medical Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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