Z-1420-2023 Class II Ongoing
FDA device recall Z-1420-2023 was initiated by Baxter Healthcare Corporation on March 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
- April 26, 2023
- Initiation Date
- March 20, 2023
- Termination Date
- N/A
- 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