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.
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' 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.
Related recalls
Same manufacturer · ICU Medical Inc
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · cgmp deviations
See all →- ModerateFentanyl Citrate Injectable Solution Recall Due to cGMP Deviations
FDA (Drugs) · 2026-05-06
- ModerateGlenmark Pharmaceuticals Recalls Pravastatin Sodium Tablets 80mg
FDA (Drugs) · 2025-04-16
- ModerateGlenmark Lacosamide 100mg Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2025-04-16
- ModerateDrug Recall: APAP 500 mg Phenyl HCl Tablets for CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModerateMigrenol Caplet Drug Recalled for CGMP Deviations
FDA (Drugs) · 2022-02-16