ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

On 09/26-29/2025, ASP Global emailed an URGENT MEDICAL DEVICE RECALL Letter to customers. ASP Global, LLC, is voluntarily recalling all RAM Scientific SAFE-T-FILL products within remaining expiry. ASP Global was made aware that our contract manufacturer for the RAM Scientific SAFE-T-FILL products was issued an FDA Warning Letter citing significant violations of the Quality System requirements, including inadequate production and process controls, as well as design controls. Customers are instructed to: a) Discontinue use of the recalled products immediately. b) Quarantine any remaining inventory to prevent further use. c) If critical or abnormal test results were obtained using the affected SAFE-T-FILL products, ensure they are verified through repeat or confirmatory testing in accordance with institutional protocols (e.g., venous confirmation of abnormal pediatric screening results). d) Dispose remaining inventory in accordance with your local facility guidelines or notify ASP Global at FieldActions@aspglobal.com for return authorization and disposal. e) Complete and return the Recall Response Form to confirm receipt and actions to FieldActions@aspglobal.com. For questions or assistance - contact FieldActions@aspglobal.com (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM ET

• FDA enforcement recordOfficial FDA database entry for Z-0545-2026
• FDA 510(k) clearance · K983517The device's official FDA premarket clearance record
• FDA device classification · JKAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1675The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ASP Global, LLC. dba Anatomy Supply Partners, 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.