Angiodynamics, Inc. Recall 93744
Description: PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
Angiodynamics, Inc. Recall 93744 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1010-2024 |
| Event ID | 93744 |
| Event Description | PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423. |
| Product Type | Devices |
| Distribution | United States (MD, LA & UT), Austria, Canada and Spain. |
| Quantity | 7 eaches |
| Recall Reason | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. |
| Device Classification | 20240214 |
| Device Code Info | UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344. |
| Center Classification Date | 20240207 |
| Recall Initiation Date | 20231218 |
| Recalling Firm | Angiodynamics, Inc. |
| Initial Notification | Letter |
| Similar To |