Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Reported: April 12, 2023 Initiated: March 1, 2023 #Z-1343-2023
Product Description
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
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
Details
- Recalling Firm
- Stryker Corporation
- Units Affected
- 1730 units (packs of 10)
- Distribution
- US Nationwide distribution.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS. Recalled by Stryker Corporation. Units affected: 1730 units (packs of 10).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 12, 2023. Severity: Moderate. Recall number: Z-1343-2023.
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