Reported Feb 14, 2024 · Ongoing
PulseSpray Infusion System devices including
Angiodynamics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619
Is this the product you have?
PulseSpray Infusion System devices including
3 of 3 products
| Model / number | Product as published |
|---|---|
12500404 | PULSE SPRAY 5F/135/20, UPN: H787125004045 |
12500415 | Pulse Spray 3Fx135x20, UPN: H787125004155 |
12500423. | and PULSE SPRAY 5F/45/10, UPN: H787125004235 |
- Lot codes and dates
- UDI-DI15051684013109
- REF12500404
- Lot5795345
- UDI-DI15051684013215
- REF12500415
- Lot5793480
- UDI-DI15051684013291
- REF12500423
- Lot5795344
- Amount recalled
- 7 eaches
Where it was sold
Why it was recalled
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Angiodynamics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.