FDAFDA · Food and drugs·Recall number Z-1346-2016
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 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.
Published April 13, 2016 · Recall initiated: November 3, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AngioDynamics Inc.
- Distributor
- US Nationwide in the states of CA, IL, MA, SC, TX
- Lot
- Batch/Lot No. 4931728, 4933094; Use By 2017-03
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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