AMUSA Recalls 0.9% Sodium Chloride Flush Syringes Due to Incorrect Expiration Date
MRP, LLC dba AMUSA is recalling 200,000 units of 0.9% Sodium Chloride Injection Flush Syringes because the labels display an incorrect expiration date.
The agency’s classification
FDA (Devices): 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 due to a labeling error (incorrect expiration date). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity level.
Plain-English summary
MRP, LLC dba AMUSA is recalling 200,000 units of 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Code No. 2T0806. The recall was initiated because the product labels contain an incorrect expiration date.
The affected products were distributed in the United States to the states of Ohio, Pennsylvania, Alabama, Illinois, Tennessee, and Connecticut. The specific lot codes involved in this recall are KH04103, KH04104, and KH04105.
Healthcare providers and consumers should check their inventory for these specific lot codes and stop using the product if the expiration date on the label does not match the correct date. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
- Manufacturer
- MRP, LLC dba AMUSA
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 200,000
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)
- CODES: KH04103
- KH04104
- KH04105
Distribution
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