CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report

Namic Convenience Kit Holyoke Hospital Special Procedure Kit recalled

AngioDynamics is recalling Namic Convenience Kit Holyoke Hospital Special Procedure Kit, distributed nationwide in the US. The recall was initiated on 3 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch/Lo. 4925662 Use By 2017-02

Quantity recalled8 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1345-2016
FDA event ID: 72957
Recalling firm: AngioDynamics, Glens Falls, NY
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2015
FDA classified: 7 Apr 2016
Reported: 13 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

3 Nov 2015	Recall initiated by company
7 Apr 2016	Classified by FDA	+156 days
13 Apr 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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".

Product as listed by the FDA

NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 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

Where it was distributed

US Nationwide in the states of CA, IL, MA, SC, TX

Nationwide California Illinois Massachusetts South Carolina Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Batch/Lo. 4925662 Use By 2017-02

Where was it sold?

US Nationwide in the states of CA, IL, MA, SC, TX

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 72957

This product is part of a recall event; the main page for the event is Namic Convenience Kit Self Regional Healthcare Pv Leg Pack recalled.

Reported	Class	Recall	Company	Reason	Where
13 Apr 2016	CLASS II	Namic Convenience Kit Self Regional Healthcare Pv Leg Pack recalled	AngioDynamics	Other	Nationwide
13 Apr 2016	CLASS II	Namic Convenience Kit Mercy General Hospital Neuro Kit recalled	AngioDynamics	Other	Nationwide
13 Apr 2016	CLASS II	Namic Convenience Kit Renown Regional Medical Center recalled	AngioDynamics	Other	Nationwide

More recalls from AngioDynamics

All 100

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide