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.
Check against the official notice below — it lists the full affected range.
Terumo Cardiovascular Systems Corporation has recalled 12 sternal retractor devices with distal connection mechanisms and articulating arms due to a potential fracture hazard. The stainless steel locking plates on the device's sternal retractor locking mechanism may fracture during use. The affected devices were distributed nationwide across New Hampshire, Wisconsin, New Jersey, Pennsylvania, Nevada, Maryland, and Tennessee, and can be identified by catalog number T401163 and serial numbers T00393 through T00412.
The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Reason for recall: There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. Distribution: US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA. Quantity: 12 Lot/code info: GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.