Home / Recalls / Medical Devices
Terumo Cardiovascular Systems Corporation recalls Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an a
Recalled April 14, 2021 · FDA recall Z-1367-2021 · Terumo Cardiovascular Systems
Hazard
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. · FDA Class II
Units
12
Sold at
US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
Description
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
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.
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →