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Pulse*spray® infusion systems 3fx135x120
Official notice
5 Jan 2024
Last checked
5 Jan 2024
An official Health Canada notice concerns Pulse*spray® infusion systems 3fx135x120. Angiodynamics, Inc., is conducting a medical device recall to the end user level based on information received from ICU medical (Smith Medical), the manufacturer of the non-sterile high-pressure rotator which are components of the sterile Angiodynamics Pulse*Spray® Infusion Catheter Systems. ICU medical has determined that specific non-sterile high-pressure rotator lots, listed in their supplier notification dated November 16, 2023, contain a manufacture defect. As stated in the information provided by ICU medical, "The inner diameter of the device's [rotating adaptor's] o-ring may be oversized affecting seal integrity." Angiodynamics has confirmed that the affected Pulse*Spray® Infusion Systems were distributed to end users located in the United States, Europe, and Canada. Angiodynamics began distributing Pulse*Spray® Infusion Systems affected by this recall globally on August 29, 2023. Angiodynamics has not received any complaints associated with the affected Pulse*Spray® Infusion Systems or reports of patient injury as a result of this issue. Recall start date: December 18, 2023 Published 2024-01-05.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74863
Official notice
2024-01-05
The hazard
The hazard
Angiodynamics, Inc., is conducting a medical device recall to the end user level based on information received from ICU medical (Smith Medical), the manufacturer of the non-sterile high-pressure rotator which are components of the sterile Angiodynamics Pulse*Spray® Infusion Catheter Systems. ICU medical has determined that specific non-sterile high-pressure rotator lots, listed in their supplier notification dated November 16, 2023, contain a manufacture defect. As stated in the information provided by ICU medical, "The inner diameter of the device's [rotating adaptor's] o-ring may be oversized affecting seal integrity." Angiodynamics has confirmed that the affected Pulse*Spray® Infusion Systems were distributed to end users located in the United States, Europe, and Canada. Angiodynamics began distributing Pulse*Spray® Infusion Systems affected by this recall globally on August 29, 2023. Angiodynamics has not received any complaints associated with the affected Pulse*Spray® Infusion Systems or reports of patient injury as a result of this issue. Recall start date: December 18, 2023
How to check if you're affected
How to check if you're affected
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Company & contacts
Brand: Analytic Technology, Pulse*spray® Infusion 3fx135x120.
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