Z-0806-2018 Class II Terminated
FDA device recall Z-0806-2018 was initiated by Baxter Healthcare Corporation on Feb 6, 2018 and is designated Class II. 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). The recall status is terminated (terminated Apr 2, 2021). Affected quantity: 2,800 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 7, 2018
- Initiation Date
- Feb 6, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0806-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026