Recall Z-0567-2026 ยท GIO Tube, Collection, Capillary Blood
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
| 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 | 27100 |
| Distribution | Distribution US nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.