Recalls / —

—#161594

Product

Newton Wire Guide

FDA product code

DQX — Wire, Guide, Catheter

Device class

Class 2

Medical specialty

Cardiovascular

Affected lot / code info

Catalog #THSCFNB-/-BH TSCFNA-BH TSCFNB-/-BH TSFNA-/-BH TSFNB-/-BH Affected lots range from: 3733537 - 5803299 F3762971 - F4692445 NS5043714 - NS5900771 3766161 - 5925080 F3753484 - F4887253 NS4938982 - NS5932560 F4556472 - F4718761 NS6024246 3741877 - 5929842 F3749985 - F4903656 NS4928037 - NS5963186 3744567 - 6253002 F3763300 - F4900931 NS4928039 - NS59824 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180

Why it was recalled

Label does not state that the product is heparin-coated.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

On October 31, 2017 an URGENT MEDICAL DEVICE CORRECTION was issued to customers requesting the following, including a corrective action: Step 1: Determine if your product is included in the affected lot ranges by comparing your lot number to the listing provided. " If your product is not affected, complete the Acknowledgement and Receipt Form. " If your product is affected, proceed to Step 2. Step 2: Remove a Heparin Coated label from the label sheet provided and apply to the top right corner of your affected unit. o If you need additional labels, please contact Stericycle at 855.215.4967. If you would like assistance, representatives are available to support you. To request assistance, please contact Stericycle at 855.215.4967

Recalling firm

Firm

Cook Inc.

Address

750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern

Nationally

Timeline

Recall initiated

2017-10-13

Terminated

2019-10-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #161594. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.