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AngioDynamics Inc. recalls NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111
Recalled April 13, 2016 · FDA recall Z-1343-2016 · AngioDynamics
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". · FDA Class II
Units
136 kits
Sold at
US Nationwide in the states of CA, IL, MA, SC, TX
Description
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
Manufacturer(s)
AngioDynamics Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →