Z-2432-2019 Class III Terminated
FDA device recall Z-2432-2019 was initiated by Baxter Healthcare Corporation on Jun 27, 2019 and is designated Class III. Reason for recall: EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. The recall status is terminated (terminated Nov 2, 2020). Affected quantity: 2192000 syringes.
Recall details
- Product Type
- Devices
- Report Date
- Sep 4, 2019
- Initiation Date
- Jun 27, 2019
- Termination Date
- Nov 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2192000 syringes
Product description
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
Reason for recall
EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
Distribution pattern
Nationwide
Code information
REF H9388105, Lot Numbers: B301N017P, B301N070P, B302M338P, B304N045P REF H9388505, Lot Numbers: B301N023P, B301N049P, B302N077P REF H93884205, Lot Numbers: B301N056P, B302M333P, 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-2432-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026