Reported Oct 30, 2013 · Terminated
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Aesculap, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aesculap, Inc. · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
- Lot codes and dates
- RT040R, all lot numbers
- Amount recalled
- 217
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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