Stryker Color Cuff Non-Sterile Disposable Tourniquet recall
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Why was Stryker Color Cuff Non-Sterile Disposable Tourniquet 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 07613327606133 Lot Numbers: 2022111801 2022112903 2022121201 2022121202 2022121203 2022121204 2022121205 2022121206
- Product
- Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
- Recalling firm
- Stryker Corporation
- Quantity
- 1730 units (packs of 10)
- Distribution
- US Nationwide distribution.
- Recall date
- April 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)