Recall Z-0545-2026 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
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.
| Date | Nov 19, 2025 (initiated Sep 26, 2025) |
| Status | Open, Classified |
| Reason | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| Root cause | Process change control |
| Action | 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 invent |
| Quantity | 50050 |
| Distribution | Distribution US nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983517 | SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM Ram Scientific, Nov 12, 1998 |