FDA Device recall Z-0593-2020
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 592…
- FDA Device
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 592… by Stryker Instruments Div, citing there is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0593-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-06 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.
Reason
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Identifiers
| code_info | GTIN: 37613154599296, Lot Numbers 60180374, 60181194 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Stryker Instruments Div recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0593-2020%22
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