Device 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.
Z-1010-2024
Product summary
- Event
- Event 93744
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 eaches
- Official record key
device-enforcement:Z-1010-2024
Official wording
Reason: Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
Code information: UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.
Distribution pattern: United States (MD, LA & UT), Austria, Canada and Spain.
Derived failure modes
-
Manufacturing or process control
manufacturing defect