FDA-Device2024-02-14Class II
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.
Angiodynamics, Inc.
Hazard
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
Sold states
United States (MD, LA & UT), Austria, Canada and Spain.
Affected count
7 eaches
Manufactured in
603 Queensbury Ave, Queensbury, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2024Don't want to check this manually?
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