Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
- Recall Initiated
- March 2, 2021
- Terminated
- November 5, 2021
- Recall Number
- Z-1367-2021
- Quantity
- 12
- Firm Location
- Elkton, MD
Reason for Recall
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Distribution
US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
Lot / Code Info
GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.
Root Cause
Employee error
Action Taken
A customer notification letter will be issued on 03/15/2021 by 2-day FedEx mailing to all (8 total) end users who have received affected product. Terumo CVS will provide a replacement device concurrent with the mailing. Customers will be advised to remove the affected product from use and to return product to Terumo CVS using the instructions provided in the customer letter.