FDA-Device2018-03-07Class II
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
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-0806-2018More Baxter Healthcare Corporation recalls
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Baxter operating table head positioning adapter recalled for loosening risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom Volara P.Circuit 5Kit breathing device recalled for nebulizer cup leakage risk
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