—#142586

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

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Batch/Lot No. 4921353 Use By 2018-05 and Batch/Lot No. 4932710 Use By 2018-06-30

Why it was 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".

Root cause (FDA determination)

Process control

Action the firm took

On November 03, 2015, Navilyst Medical distributed Urgent Voluntary Medical Device Recall notices to their customers via courier service. Customers were advised to immediately remove the recall product from inventory and to segregate the products in a secure location for return to AngioDynamics, Inc. Customers should immediately forward a copy of the recall notification letter to all sites if these products were further distributed. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday EST) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return). The Reply Verification Tracking form can be submitted via fax to: Attn: Convenience Kits - Procedure Products Needles 1-800-782-1357 or via email to rdenino@angiodynamics.com or sbaxter@angiodynamics.com.

Recalling firm

Firm: AngioDynamics Inc.
Address: 10 Glens Falls, Tech Park Glens Falls, New York 12801-3864

Distribution

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

Timeline

Recall initiated: 2015-11-03
Posted by FDA: 2016-04-07
Terminated: 2017-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142586. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.