FDA-Device2025-11-26Class IIPROCESSING DEFECT

SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

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
16920
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2026

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