Medical device recalls Moderate risk

MRP, LLC dba AMUSA product recalled over labeling errors

Recall date
February 9, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
MRP, LLC dba AMUSA recalls T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only…
Recall number
Z-1808-2015
FDA classification
Class II
Brand / firm
MRP, LLC dba AMUSA
Sold / distributed
US distribution to CA only.

Why it was recalled

Incorrect labeling of the expiration date

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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