Hemodialysis vascular access kit recalled due to metal shavings risk
DURAMAX hemodialysis vascular access kits are recalled due to potential metal shavings that could enter the bloodstream and require surgical removal. Thirty units distributed in Virginia are affected.
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 classification with no reported injuries or deaths. However, the potential for serious harm from metal shavings entering the bloodstream and requiring surgical intervention qualifies this as a high-risk product where injury has not yet been reported, per the rubric.
Plain-English summary
Angiodynamics, Inc. is recalling DURAMAX STACKED TIP 28CM STR. BASIC KIT (Product Number H787103028041), used for long-term vascular access in hemodialysis and apheresis patients.
The recall is due to the potential presence of loosely affixed metal shavings in the device. These shavings could separate and enter the bloodstream, a condition called embolization, potentially requiring surgical removal.
The recall affects 30 units distributed in Virginia. The affected lot number is 5805840.
Patients and healthcare providers who have received or implanted these devices should immediately consult their healthcare provider for evaluation and potential removal of the device if necessary.
The recalled product
- Product
- DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- metal-shavings
- embolization
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 (1)
- UDI-DI: 15051684011846 Lot Numbers: 5805840
Distribution
Distributed in 1 state:
- VA
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03