medical Class II Updated 2021-04-14

Terumo Cardiovascular Systems Corporation recalls Consist of a distal connection mechanism (either standard Te

Recalled 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.

Hazard / Issue

There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.
View official government recall

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