Recall Z-1367-2021
Terumo Cardiovascular Systems Corporation · initiated March 2, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.
Reason for recall
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
FDA-determined 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.
Details
- Recall number
- Z-1367-2021
- Initiated
- March 2, 2021
- Terminated
- November 5, 2021
- Product code
- MWS – Stabilizer, Heart
- Quantity
- 12
- Distribution
- US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Elkton, MD