Z-0050-2020 Class III Terminated
FDA device recall Z-0050-2020 was initiated by Baxter Healthcare Corporation on Aug 13, 2019 and is designated Class III. Reason for recall: Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers. The recall status is terminated (terminated Nov 23, 2020). Affected quantity: 2,719,200 dispenser units.
Recall details
- Product Type
- Devices
- Report Date
- Oct 16, 2019
- Initiation Date
- Aug 13, 2019
- Termination Date
- Nov 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,719,200 dispenser units
Product description
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 for recall
Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
Distribution pattern
Worldwide distribution - including US Nationwide distribution, and country of Canada.
Code information
(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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0050-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026