PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 13, 2016 Initiated: November 3, 2015 #Z-1343-2016

Product Description

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".

Details

Recalling Firm
AngioDynamics Inc.
Units Affected
136 kits
Distribution
US Nationwide in the states of CA, IL, MA, SC, TX
Location
Glens Falls, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by AngioDynamics Inc.. Units affected: 136 kits.
Why was this product recalled?
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".
Which agency issued this recall?
This recall was issued by the FDA Devices on April 13, 2016. Severity: Moderate. Recall number: Z-1343-2016.