FDA-Device2022-02-09Class II

Premier Rotaclone, Rx only

MEDLINE INDUSTRIES, LP - Northfield
Hazard

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Sold states
US Nationwide distribution in the states of California and Massachusetts.
Affected count
34 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Premier Rotaclone, Rx only

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0552-2022

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