Recall Z-1341-2023 ยท KCY Tourniquet, Pneumatic
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
| Date | Apr 4, 2023 (initiated Mar 1, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Recall letter dated 2/27/23 via 2-day Fedex delivery. The purpose of this letter is to inform you of an increase in reported low pressure events for specific lots of Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs and to reiterate the steps in the Instructions For Use (IFU) to mitigate the risk to achieve or maintain pressure. Letter states reason for recall, health risk and action to take: Please review all action steps below and complete the acknowledgement section (pg.3) of this letter and return by email to Instruments.recalls@stryker.com. 1. |
| Quantity | 1979 units (packs of 10) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.