PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks
Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall affecting a drug-delivery device with a manufacturing defect that could compromise function. No illnesses or injuries are reported in the source; the hazard is theoretical. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' warranting a High (3) severity score.
Plain-English summary
Angiodynamics, Inc. is recalling specific PulseSpray Infusion System devices (models PULSE SPRAY 5F/135/20, Pulse Spray 3Fx135x20, and PULSE SPRAY 5F/45/10) because of a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity.
A defective O-ring can fail to maintain a tight seal during medication infusion, potentially allowing medication to leak. This defect affects the reliability of the seal under normal use conditions.
Affected devices were distributed to healthcare facilities in the United States (Maryland, Louisiana, and Utah), as well as Austria, Canada, and Spain. Healthcare providers and device users should immediately discontinue use of affected lots and contact Angiodynamics or the FDA for guidance on device replacement or return.
Patients or healthcare workers who have concerns about prior use of these devices should contact their healthcare provider or Angiodynamics for instructions on management and follow-up.
The recalled product
- 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
- Angiodynamics, Inc.
- Hazard
- manufacturing-defect
- seal-failure
- medication-leak
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- UDI-DI: 15051684013109
- REF: 12500404
- Lot: 5795345
- UDI-DI: 15051684013215
- REF: 12500415
- Lot: 5793480
- UDI-DI: 15051684013291
- REF: 12500423
- Lot: 5795344.
Distribution
Distributed in 3 states:
- LA
- MD
- UT
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