Recall Z-0806-2018 ยท KYZ Syringe, Irrigating (Non Dental)
Baxter Healthcare Corporation
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
| Date | Feb 6, 2018 |
| Status | Terminated |
| Reason | Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL). |
| Root cause | Employee error |
| Action | Customers were notified via letter on about 02/06/2018. Instructions include to locate and remove affected product in inventory, confirm mislabeled 5 mL oral dispensers (Lot number 1203395) in the individual pouch are not mixed together with 1 mL oral dispensers (Product code H93876101) or other stored product, contact Baxter Healthcare Center to arrange return of affected product, and complete and return the customer reply form if purchased directly from Baxter. Also, customer are instructed to notify customers and conduct a consumer-level recall if the affected product was further distribu |
| Quantity | 2,800 units |
| Distribution | Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.