FDAFDA · Food and drugs·Recall number Z-0031-2014
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Published October 30, 2013 · Recall initiated: July 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- RT040R, all lot numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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