FDA-Device2016-04-13Class II
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.
AngioDynamics Inc.
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".
Sold states
US Nationwide in the states of CA, IL, MA, SC, TX
Affected count
45 kits
Manufactured in
10 Glens Falls Tech Park, N/A, Glens Falls, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2016Don't want to check this manually?
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