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Angiodynamics, Inc. recalls PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx1
Recalled February 14, 2024 · FDA recall Z-1010-2024 · Angiodynamics
Hazard
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. · FDA Class II
Units
7 eaches
Sold at
United States (MD, LA & UT), Austria, Canada and Spain.
Description
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
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.
Manufacturer(s)
Angiodynamics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →