Recall Z-0031-2014— Aesculap, Inc.
Class II · Terminated
Class II FDA medical device recall by Aesculap, Inc., initiated 2013-07-16, terminated 2014-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.. Reason: 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..
- Recalling firm
- Aesculap, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-16
- Terminated
- 2014-08-26
- Firm location
- Center Valley, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.