Product Recall  from ASP Global, LLC.

This voluntary recall has been initiated by ASP Global, LLC for the following reasons:

• Certain products manufactured between September 2016 and March 2023 are labeled with a 10-year expiration date, while the documentation states a 5-year shelf life.

Note: This recall should be carried out between the customer and ASP Global, LLC.

ASP Global, Expressaire, and MPR Branded STERILE DISPOSABLE TOURNIQUET CUFF

What is the issue?
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.

As a result, ASP Global is voluntarily recalling affected products that remain within their labeled expiration date.

Risk to Health:

To date, ASP Global has received no adverse events associated with this issue. There have been no reported serious injuries or deaths associated with the issue. Products used within the validated 5-year shelf life are not expected to present additional risk. For products used beyond 5 years from the date of manufacture, the Tourniquet Cuff performance and sterility cannot be assured because supporting validation data are unavailable beyond the
validated shelf life.

Status : Open

Please review the instructions below and submit your response(s) to ASP Global, LLC.

Instructions

Please take the following actions immediately:

1. Review Appendix A in the Customer Recall and Instructions PDF to identify affected item codes and lot numbers.
2. Discontinue use of the affected products.
3. Quarantine any remaining impacted inventory to prevent further use.
4. Complete and return the Recall Response Form to confirm receipt and actions to FieldActions@aspglobal.com.
5. Dispose remaining inventory in accordance with your local facility’s guidelines or notify ASP Global at FieldActions@aspglobal.com for return authorization and disposal assistance.
6. If you distributed affected products to other facilities or customers, please notify those
   recipients of this recall and provide them with a copy of this notification.

Affected Product and Lost List

  Expressaire Branded Sterile Tourniquet Cuff Products Affected Item Codes

  ASP Global Branded Sterile Tourniquet Cuff Products Affected Item Codes

  MPR Branded Sterile Tourniquet Cuff Products Affected Item Codes