CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report
Namic Convenience Kit Self Regional Healthcare Pv Leg Pack recalled
AngioDynamics is recalling Namic Convenience Kit Self Regional Healthcare Pv Leg Pack, 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
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-1343-2016
- 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 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
Where it was distributed
US Nationwide in the states of CA, IL, MA, SC, TX
Nationwide CaliforniaIllinoisMassachusettsSouth CarolinaTexas
Questions about this recall
Is Namic Convenience Kit Self Regional Healthcare Pv Leg Pack recalled?
Yes. AngioDynamics recalled Namic Convenience Kit Self Regional Healthcare Pv Leg Pack on 3 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-1343-2016.
Why was it 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 lots are affected?
Batch/Lot No. 4921353 Use By 2018-05 and Batch/Lot No. 4932710 Use By 2018-06-30
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Soft-Vu Angiographic Catheter, Headhunter , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
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