FDA-Device2016-11-09Class II

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

B. Braun Medical, Inc.
Hazard

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.

Sold states
US Distribution to: AL, IL, OK, MN, MA and WI.
Affected count
1704 units
Manufactured in
901 Marcon Blvd, Allentown, PA, United States
Products
Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0327-2017

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