Angiodynamics, Inc.: PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5

Hazard

Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.

Details from the source

Reason for recall: Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. Distribution: United States (MD, LA & UT), Austria, Canada and Spain. Quantity: 7 eaches Lot/code info: UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.

UPC codes

15051684013109, 15051684013215, 15051684013291

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.