Angiodynamics recalls PulseSpray Infusion Systems with a manufacturing defect that may cause medication leaks during use. Affected models include PULSE SPRAY 5F/135/20 and others. Stop using immediately to prevent potential medication leaks.
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
Angiodynamics is recalling PulseSpray Infusion Systems that may leak medication due to a defective O-ring. This could lead to improper medication delivery if the device is used without the seal being intact.
A manufacturing defect in the rotating adaptor O-ring can cause the seal to fail during medication infusion. This may lead to medication leaks, potentially causing improper dosing or contamination.
Patients using the PulseSpray Infusion System for medication delivery are most at risk. The recall affects specific model numbers and production lots.
Check for model numbers like PULSE SPRAY 5F/135/20, UPN: H787125004045, or REF: 12500404. The recall includes specific production lots and unique identifiers listed in the official notice.
Identify your PulseSpray Infusion System model number and production lot to confirm if it is affected.
If your device is affected, stop using it to prevent medication leaks during infusion.
Affected models include 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).
Check the model number and production lot on your device. Affected units have specific UPNs and REF numbers listed in the recall notice.
Stop using the device immediately to prevent medication leaks. Contact Angiodynamics for further instructions.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1010-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1010-2024 from Angiodynamics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
