Medical device recalls Moderate risk

B. Braun Medical, Inc. recalls Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthe…

Recall date
July 11, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0327-2017
FDA classification
Class II
Brand / firm
B. Braun Medical, Inc.
Sold / distributed
US Distribution to: AL, IL, OK, MN, MA and WI.

Why it was recalled

B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection, USP that Hospira Inc. has recalled because the drug product does not meet the specification for color throughout shelf life.

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

What was recalled

Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia

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