FDA-Device2025-11-26Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices
Hazard

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

Intended for
All ages
Illnesses reported
None reported
Sold states
Distribution US nationwide and Canada.
Affected count
620502
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2026

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