Device product
ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
Z-1420-2023
Product summary
- Event
- Event 91888
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 91,100 units
- Official record key
device-enforcement:Z-1420-2023
Official wording
Reason: ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
Code information: Lot Number B301S356P
Distribution pattern: US
Derived failure modes
-
Foreign material or chemical contamination
particulate matter