Z-1342-2023 Class II Ongoing
FDA device recall Z-1342-2023 was initiated by Stryker Corporation on March 1, 2023 and is designated Class II. 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 operati… The recall status is ongoing. Affected quantity: 1617 units (packs of 10).
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2023
- Initiation Date
- March 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1617 units (packs of 10)
Product Description
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
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
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN: 07613327606188 Lot Numbers: 2022111806 2022112802 2022120501 2022120502 2022120503 2022120504 2022120505 2022120701