ASP Global, LLC. recalls Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 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 surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: NoModel Number15 affected lotsA701070110088591403555901SEP2016S0823STYS0922STYS1101STYS1214STYR0601STY
+7 more
R0801STYQ0301STYN0730STYM0130STYM0930STYM1230STYL0120STY
What the firm is doing
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 prevent further use. d) Complete and return the enclosed Recall Response Form to confirm receipt and actions to FieldActions@aspglobal.com. e) Dispose remaining inventory in accordance with the local facility s guidelines or notify ASP Global at FieldActions@aspglobal.com for return authorization and disposal assistance. f) If customers have distributed affected products to other facilities or customers, notify those recipients of this recall and provide them with a copy of this notification. For questions regarding this recall, contact: ASP Global Field Actions Team Email: FieldActions@aspglobal.com Phone: (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM EST
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0032-2027
- FDA device classification · KCYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.5910The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find ASP Global, LLC.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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