Device product
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
Z-2432-2019
Product summary
- Event
- Event 83230
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2192000 syringes
- Official record key
device-enforcement:Z-2432-2019
Official wording
Reason: EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
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
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.