SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model

FDA device recall Z-0550-2026 · posted 2025-11-19 · Open, Classified

Recall details

Recalling firm

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Reason for recall

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

Action taken

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

Root cause

Process change control

Status

Open, Classified

Product code

JKA

Quantity affected

9150

Distribution

Distribution US nationwide and Canada.

Date initiated

2025-09-26

Date posted

2025-11-19

Location

Austell, GA

Related 510(k) clearances