FDA-Device2021-04-14Class II
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.
Terumo Cardiovascular Systems Corporation
Hazard
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Sold states
US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
Affected count
12
Manufactured in
125 Blue Ball Rd, N/A, Elkton, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1367-2021Don't want to check this manually?
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