FDA Device recall Z-1367-2021
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm wit…
- FDA Device
- Class II
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm wit… by Terumo Cardiovascular Systems, citing there is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1367-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-02 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
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.
Reason
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Identifiers
| code_info | GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405,…GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1367-2021%22
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