ICU Medical Recalls Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical is recalling 941,496 bags of 0.9% 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 infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
ICU Medical Inc. is recalling 941,496 bags of 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only. The product is identified by NDC 0409-7983-02 and includes Lot # 85-018-JT and 85-031-JT with an expiration date of 01/01/2020. The recall was initiated because the bags have the potential to leak, resulting in a lack of assurance of sterility.
The affected products were distributed nationwide and in Canada. This recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses or injuries associated with the use of these products.
Healthcare providers and consumers should stop using the affected lots immediately and contact their supplier or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
- Manufacturer
- ICU Medical Inc
- Category
- Drug — Injectable Solution
- Affected units
- 941,496
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 (3)
- Lot #: 85-018-JT
- 85-031-JT
- Exp. 01/01/2020
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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