FDAFDA · Food and drugs·Recall number Z-1339-2023
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Published April 12, 2023 · Recall initiated: March 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Corporation
- Distributor
- US Nationwide distribution.
- Lot
- GTIN: 07613327606157 Lot Numbers; 2022111803 2022112901 2022121911 2022121912 2022122601 2022122602
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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