Angiodynamics vascular access catheter subject to voluntary recall
Angiodynamics has voluntarily recalled 285 units of DURAMAX STACKED TIP vascular access catheters (lots 5807195 and 5807196) used for hemodialysis. The specific reason for the recall is not disclosed in the FDA notice.
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: This is a Class II recall of vascular access catheters used in critical hemodialysis procedures. Such devices are inherently risk-of-harm products; any manufacturing defect could compromise patient safety. No illnesses or injuries are reported in the source, which prevents a higher score per the rubric.
Plain-English summary
Angiodynamics, Inc. has initiated a voluntary recall of 285 units of DURAMAX STACKED TIP 28 CM STRAIGHT vascular access catheters (UDI-DI: 25051684011935). The affected lot numbers are 5807195 and 5807196. These catheters are indicated for long-term vascular access in hemodialysis and apheresis procedures.
The recall was initiated on March 18, 2024, and reported to the FDA on May 15, 2024. It is classified as Class II. The specific defect or reason for this recall is not stated in the public FDA notice. The product was distributed in Virginia.
Patients currently using these catheters should contact their healthcare provider to determine if they are affected and to discuss appropriate medical management. Healthcare facilities should verify whether they have received any of the affected lot numbers and consult with the manufacturer regarding next steps.
The recalled product
- Product
- DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- device-defect
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 (2)
- UDI-DI: 25051684011935 Lot Numbers: 5807195
- 5807196
Distribution
Distributed in 1 state:
- VA
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