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Aesculap, Inc. recalls UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Recalled October 30, 2013 · FDA recall Z-0031-2014 · Aesculap
Hazard
Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system. · FDA Class II
Units
217
Sold at
Nationwide Distribution.
Description
Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.
Product
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Manufacturer(s)
Aesculap, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →