Recall archive / FDA device enforcement
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3... — FDA record Z-1010-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 18, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
- Classification
- Class II
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 7 eaches
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1010-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
United States (MD, LA & UT), Austria, Canada and Spain.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 14, 2024
- Recall initiation date
- Dec 18, 2023
- Center classification date
- Feb 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.