Recall Z-0009-2027 ยท KCY Tourniquet, Pneumatic
ASP Global, LLC.
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surg
| Date | Oct 1, 2026 (initiated Aug 24, 2026) |
| Status | Open, Classified |
| Reason | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. |
| Root cause | Under Investigation by firm |
| Action | On 08/24/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that, ASP Global identified a discrepancy between the labeled shelf life and available shelf-life validation data for certain Sterile Disposable Tourniquet Cuff products. While affected products were labeled with a 10-year shelf life, available validation documentation supports a shelf life of 5-years. Customer are instructed to: a) Review Appendix A to identify affected item codes and lot numbers. b) Discontinue use of the affected products. c) Quarantine any remaining impacted inventory to preven |
| Quantity | 38380 |
| Distribution | US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.