FDAClass IIApril 13, 2016

Namic Convenience KIT Holyoke Hospital Special recall

NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is…

Why was Namic Convenience KIT Holyoke Hospital Special 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".

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch/Lo. 4925662 Use By 2017-02

Product
NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is…
Recalling firm
AngioDynamics Inc.
Quantity
8 kits
Distribution
US Nationwide in the states of CA, IL, MA, SC, TX
Recall date
April 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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