FDA-Device2021-06-30Class II

OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326

Cardinal Health Inc.
Hazard

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

Sold states
US Nationwide distribution in the states of FL, GA, SC.
Affected count
375 units
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1941-2021

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