Z-0806-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- February 6, 2018
- Termination Date
- April 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,800 units
Product Description
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Reason for Recall
Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
Distribution Pattern
Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.
Code Information
Lot No. 1203395, Expiration Date 11/30/2019