FDA-Device2025-11-26Class IIPROCESSING DEFECT

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 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
121750
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0563-2026

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