FDA Device recall Z-0806-2018
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105 by Baxter Healthcare, citing affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0806-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-06 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | IL, MA, MD, OH, SD, TX, VA, WI |
Product
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
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).
Identifiers
| code_info | Lot No. 1203395, Expiration Date 11/30/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0806-2018%22
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