Device 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
Z-1340-2023
Product summary
- Event
- Event 91849
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1206 units (packs of 10)
- Official record key
device-enforcement:Z-1340-2023
Official wording
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
Code information: GTIN: 07613327606195 Lot Numbers: 2022111804 2022112902 2022121909 2022121910 2022122603 2022122604
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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