FDA Device recall Z-1343-2016

NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This…

FDA Device
Class II
terminated
Published 2016-04-13

On 2016-04-13 the FDA classified a Class II recall of NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This… by Angiodynamics, citing 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 unabl….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1343-2016
Classification	Class II
Status	terminated
Initiated	2015-11-03
Published	2016-04-13
Last updated	2026-09-13 11:54 UTC
Company	Angiodynamics
Distribution	US

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

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".

Identifiers

code_info	Batch/Lot No. 4921353 Use By 2018-05 and Batch/Lot No. 4932710 Use By 2018-06-30

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1343-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.