FDA Device recall Z-0050-2020
EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100
- FDA Device
- Class III
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class III recall of EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100 by Baxter Healthcare, citing exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0050-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-08-13 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent administration of liquid medication and nutrition to humans through the patient s mouth.
Reason
Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
Identifiers
| code_info | (a) REF H9388105, Lot Numbers: B301N017P, B301N070P, B304N045P (b) REF H9388505, Lot Numbers: B301N023P, B301N049P,…(a) REF H9388105, Lot Numbers: B301N017P, B301N070P, B304N045P (b) REF H9388505, Lot Numbers: B301N023P, B301N049P, B302N077P, B303N108P (c) REF H93884205, Lot Numbers: B301N056P, B303N042P, B307N015P |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0050-2020%22
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