Device product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Z-1342-2023
Product summary
- Event
- Event 91849
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1617 units (packs of 10)
- Official record key
device-enforcement:Z-1342-2023
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: 07613327606188 Lot Numbers: 2022111806 2022112802 2022120501 2022120502 2022120503 2022120504 2022120505 2022120701
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