NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Pr

FDA device recall Z-1343-2016 · posted 2016-04-07 · Terminated

Recall details

Recalling firm

AngioDynamics Inc.

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".

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

OEZ

Quantity affected

136 kits

Distribution

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

Date initiated

2015-11-03

Date posted

2016-04-07

Date terminated

2017-03-16

Location

Glens Falls, NY