Medical device recalls Moderate risk

MRP, LLC dba AMUSA recalls 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

Recall date
July 2, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2476-2015
FDA classification
Class II
Brand / firm
MRP, LLC dba AMUSA
Sold / distributed
Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.

Why it was recalled

Procedures for the acceptance and control of in-process product have not been adequately established.

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

What was recalled

0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

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