DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
Reported: May 15, 2024 Initiated: March 18, 2024 #Z-1763-2024
Product Description
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
Reason for Recall
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Details
- Recalling Firm
- Angiodynamics, Inc.
- Units Affected
- 188 units
- Distribution
- VA
- Location
- Queensbury, NY
Frequently Asked Questions
What product was recalled? ▼
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115. Recalled by Angiodynamics, Inc.. Units affected: 188 units.
Why was this product recalled? ▼
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2024. Severity: Moderate. Recall number: Z-1763-2024.
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