Recall Z-1157-2024 ยท KYZ Syringe, Irrigating (Non Dental)
MEDLINE INDUSTRIES, LP - Northfield
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
| Date | Sep 30, 2024 (initiated Jan 4, 2024) |
| Status | Open, Classified |
| Reason | Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001). |
| Root cause | Under Investigation by firm |
| Action | Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to its consignees on 01/04/2024 via USPS First Class. The notice explained the problem with the device, risk involved, and requested the consignee quarantine then destroy the affected product. Upon receipt of the completed destruction form, firm will issue credit, if applicable. Consignee was directed to notify all parties of this action to whom the product was distributed. For questions, contact 866-359-1704 |
| Quantity | 4831 units |
| Distribution | US, Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.