Recall Z-2432-2019 ยท KYX Dispenser, Liquid Medication
Baxter Healthcare Corporation
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
| Date | Jun 27, 2019 |
| Status | Terminated |
| Reason | EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. |
| Root cause | Under Investigation by firm |
| Action | The firm disseminated a safety alert to their consignees on 06/27/2019 by letter. The letter explained the 5mL syringes were commingled with 10mL syringes and directed the consignee separate the 5mL syringes from the 10mL syringes. |
| Quantity | 2192000 syringes |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.