UNITRAC Pneumatic Retraction Arm. A support arm used to recall
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Why was UNITRAC Pneumatic Retraction Arm. A support arm used to 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
RT040R, all lot numbers
- Product
- UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
- Recalling firm
- Aesculap, Inc.
- Quantity
- 217
- Distribution
- Nationwide Distribution.
- Recall date
- October 30, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)