Terumo Cardiovascular Systems Corporation Recall 87504
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.
Terumo Cardiovascular Systems Corporation Recall 87504 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1367-2021 |
| Event ID | 87504 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA. |
| Quantity | 12 |
| Recall Reason | There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. |
| Device Classification | 20210414 |
| Device Code Info | GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412. |
| Center Classification Date | 20210406 |
| Recall Initiation Date | 20210302 |
| Recalling Firm | Terumo Cardiovascular Systems Corporation |
| Initial Notification | Letter |
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