Device product

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube

Z-0556-2026

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: 209000
Official record key: device-enforcement:Z-0556-2026

Official wording

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

Code information: Model Number: 06 0508 GTIN : 30643351000384 UDI-DI: 10643351000380 All Lots produced from 1AUG2020 to 28FEB2025: 21F4062, 21L4388, 22G4487, 23C4341, 23F4164, 23G4172, 23G4210, 24I4053, 24I4327, 24I4330, 24I4331, 24I4409, 24J4141, 24J4350

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