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.
Reported: April 14, 2021 Initiated: March 2, 2021 #Z-1367-2021
Product Description
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.
Reason for Recall
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 12
- Distribution
- US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
- Location
- Elkton, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 12.
Why was this product recalled? ▼
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1367-2021.
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