ICU Medical Recalls 0.9% Sodium Chloride Injection Due to CGMP Deviations
ICU Medical Inc. is voluntarily recalling 475,320 bags of 0.9% Sodium Chloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.
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' rating under the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.
Plain-English summary
ICU Medical Inc. has initiated a voluntary recall of 475,320 bags of 0.9% Sodium Chloride Injection, USP 1000 mL flexible container. The product is identified by NDC 0409-7983-09, Lot # 91-016-JT, and an expiration date of July 01, 2020. The recall was initiated on February 4, 2019, and is classified as Class II by the FDA.
The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide within the United States. The recall was initiated by the firm and is currently terminated.
Consumers and healthcare providers 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. No specific instructions for disposal or patient management are provided in the source text beyond the standard recall notification.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
- Manufacturer
- ICU Medical Inc
- Category
- Drug — IV Fluids
- Hazard
- Affected units
- 475,320
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 #: 91-016-JT
- Exp. July 01
- 2020
Distribution
Distributed nationwide across the United States.
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