Recall Z-0550-2026— ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Class II · Ongoing

Class II FDA medical device recall by ASP Global, LLC. dba Anatomy Supply Partners, LLC., initiated 2025-09-26. It names one FDA 510(k) clearance: K983517. Product: SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.. Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes..

Recalling firm
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Classification
Class II
Status
Ongoing
Initiated
2025-09-26
Firm location
Austell, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.