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Recall Observatory FDA recall evidence

Device product

AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0549-2026

September 26, 2025

Class II

Product summary

Firm
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Event
Event 97592
Status
Ongoing
Classification
Class II
Quantity
49000
Official record key
device-enforcement:Z-0549-2026

Official wording

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

Code information: Model Number: 07 7220 GTIN (Inner Pack): 30643351000094 UDI-DI: 10643351000090 All Lots produced from 01AUG2023 to 28FEB2025: 23H4114, 23I4054, 23J4036, 24A4107, 24H4123, 24I4324, 24L4007

Distribution pattern: Distribution US nationwide and Canada.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    inadequate quality system to include unvalidated manufacturing processes