NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK — Class II medical device recall Z-1343-2016
Terminated recall by AngioDynamics Inc., reported 2016-04-13, distributed nationwide. Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specifi
| Recall number | Z-1343-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AngioDynamics Inc., Glens Falls, NY, United States |
| Recall initiated | 2015-11-03 |
| Classified | 2016-04-07 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 136 kits |
| Lot numbers | 2018-05, 4921353, 4932710 |
| Model numbers | 651919311 |
| Expiration dates | 2018-06-30 |
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
Reason for recall
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".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1343-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.