Device product
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Z-0806-2018
Product summary
- Event
- Event 79090
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,800 units
- Official record key
device-enforcement:Z-0806-2018
Official wording
Reason: Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
Code information: Lot No. 1203395, Expiration Date 11/30/2019
Distribution pattern: Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.
Derived failure modes
-
Labeling or packaging
mislabeled