Z-1010-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- December 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 eaches
Product 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.
Reason for Recall
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
Distribution Pattern
United States (MD, LA & UT), Austria, Canada and Spain.
Code Information
UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.