Hercules 360 Universal Stabilizing Arm recall
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Why was Hercules 360 Universal Stabilizing Arm recalled?
Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site.
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?
Serial Number Range 70194 through 70504
- Product
- Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- The total number of distributed devices stands at 260
- Distribution
- Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
- Recall date
- February 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)