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Recall Observatory FDA recall evidence

Device product

SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube

Z-0564-2026

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
620502
Official record key
device-enforcement:Z-0564-2026

Official wording

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

Code information: Model Number: 06 0402 GTIN (Inner Pack): 30643351000346 UDI-DI: 10643351000342 All Lots produced from 01AUG2020 to 28FEB2025: 22A4541, 22G4485, 22K4018, 23A4160, 23C4340, 23F4168, 23F4169, 23H4107, 23I4055, 23J4039, 24E4129, 24F4189

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