Recall Z-1340-2023— Stryker Corporation
Class II · Ongoing
Class II FDA medical device recall by Stryker Corporation, initiated 2023-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS 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.
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-01
- Firm location
- Portage, MI, United States
Product description
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.