Recall Z-1420-2023 ยท KYX Dispenser, Liquid Medication
Baxter Healthcare Corporation
ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
| Date | Apr 20, 2023 (initiated Mar 20, 2023) |
| Status | Open, Classified |
| Reason | ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/20/2023 by USPS. The notice explained the issue and the hazard and requested the following actions be taken: Immediately locate, isolate, and cease all use of the affected product. The product code and lot number can be found on the product carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001, 7:00 am and 6:00 pm Central Time, Monday - Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned rea |
| Quantity | 91,100 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.