Stryker Corporation Recall 91849
Description: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Stryker Corporation Recall 91849 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1339-2023 |
| Event ID | 91849 |
| Event Description | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 1225 units (packs of 10) |
| Recall 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 |
| Device Classification | 20230412 |
| Device Code Info | GTIN: 07613327606157 Lot Numbers; 2022111803 2022112901 2022121911 2022121912 2022122601 2022122602 |
| Center Classification Date | 20230404 |
| Recall Initiation Date | 20230301 |
| Recalling Firm | Stryker Corporation |
| Initial Notification | Letter |
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