Z-1343-2023 Class II Ongoing
FDA device recall Z-1343-2023 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: 1730 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
- 1730 units (packs of 10)
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
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN: 07613327606133 Lot Numbers: 2022111801 2022112903 2022121201 2022121202 2022121203 2022121204 2022121205 2022121206