FDA Device recall Z-1344-2023
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in…
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in… by Stryker, citing not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1344-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-01 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker |
| Distribution | US |
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Reason
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Identifiers
| code_info | GTIN: 07613327606164 Lot Numbers: 2022111802 2022112904 2022121301 2022121302 2022121905 2022121906 2022121907 2022121908 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1344-2023%22
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