Recalls / —

—#161584

Product

Amplatz Ultra Stiff Wire Guide

FDA product code

DQX — Wire, Guide, Catheter

Device class

Class 2

Medical specialty

Cardiovascular

Affected lot / code info

Catalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894

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 #161584. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.