Class II — AngioDynamics Inc.
| Recalling firm | ANGIODYNAMICS, INC |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036". |
| Product | NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire |
| Quantity | 136 kits |
| Distribution | US Nationwide in the states of CA, IL, MA, SC, TX |
| Initiated | 2015-11-03 |
| Classified | 2016-04-07 |
| Terminated | 2017-03-16 |
| Recall number | Z-1343-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AngioDynamics Inc. (Z-1343-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72957/
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