UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Reported: October 30, 2013 Initiated: July 16, 2013 #Z-0031-2014
Product Description
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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.
Details
- Recalling Firm
- Aesculap, Inc.
- Units Affected
- 217
- Distribution
- Nationwide Distribution.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.. Recalled by Aesculap, Inc.. Units affected: 217.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2013. Severity: Moderate. Recall number: Z-0031-2014.
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