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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

Product Description UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Recall Number Z-0031-2014
Classification Class II
Code Info RT040R, all lot numbers
Product Distributed Qty 217
Reason For Recall 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.

Event Detail

Event Id 65952
Product Type Devices
Status Ongoing
Recalling Firm Aesculap, Inc.
City Center Valley
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.