FDA recall Z-1010-2024

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 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.

Key facts

Status

Ongoing

Initiation date

2023-12-18

Report date

2024-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2024