Fresenius Recalls Sodium Chloride Injection Bags Due to Sterilization Issue
Fresenius Medical Care is recalling 32,592 bags of Sodium Chloride 0.9% Injection because chemical indicators were not positioned properly during sterilization.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The source text describes a CGMP deviation regarding sterilization indicators but does not report any illnesses, injuries, or deaths, nor does it explicitly state that the hazard is theoretical, placing it in the Moderate category rather than High.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 32,592 bags of Sodium Chloride 0.9% Injection, USP, 1000 mL bags. The product is prescription-only and was distributed throughout the United States.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. Specifically, chemical indicators were not positioned properly during the sterilization process. The affected lots are 19EG02012 and 19EG02019 with an expiration date of 05/2020, and 19DG02050 with an expiration date of 04/2020.
The FDA has classified this recall as Class II. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Drug — IV Fluids
- Hazard
- Affected units
- 32,592
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 (5)
- Lot #: 19EG02012
- 19EG02019
- Exp. Date 05/2020
- 19DG02050
- Exp. Date 04/2020
Distribution
Distribution scope not specified by the agency.
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