FDA-Device2018-03-07Class II
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Baxter Healthcare Corporation
Hazard
Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
Sold states
Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.
Affected count
2,800 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0806-2018Don't want to check this manually?
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