AMUSA Sterile Field Flush Syringe Recalled for Incorrect Expiration Date Labeling
MRP, LLC dba AMUSA is recalling 1,080 units of T/S2 0.9% Sodium Chloride Injection flush syringes due to incorrect expiration date labeling.
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 and involves a minor labeling error (incorrect expiration date) with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
MRP, LLC dba AMUSA is recalling 1,080 units (3 cases) of T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Part no. 2S0706. The recall is due to incorrect labeling of the expiration date.
The affected product is a prescription-only flush syringe. The distribution was limited to California, United States. The specific code for the recalled units is KH04090.
Consumers and healthcare facilities should stop using the affected syringes and contact the recalling firm for instructions on return or replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
- Manufacturer
- MRP, LLC dba AMUSA
- Category
- Medical Device — Syringes
- Hazard
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 (1)
- KH04090
Distribution
Distributed in 1 state:
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