Z-1420-2023 Class II Ongoing
FDA device recall Z-1420-2023 was initiated by Baxter Healthcare Corporation on Mar 20, 2023 and is designated Class II. Reason for recall: ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. The recall status is ongoing. Affected quantity: 91,100 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 26, 2023
- Initiation Date
- Mar 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 91,100 units
Product description
ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
Reason for recall
ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
Distribution pattern
US
Code information
Lot Number B301S356P
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1420-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026