Z-0960-2018Class II

Newton Wire Guide

Name: Z-0960-2018 Newton Wire Guide
Creator: Cook Inc.
Published: 2017-10-13
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-10-13 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of Newton Wire Guide on 2017-10-13. FDA classified it as Class II and gives the reason as "Label does not state that the product is heparin-coated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0960-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-13
Posted: 2018-03-09
Terminated: 2019-10-23
Recalling firm: Cook Incorporated
Product: Newton Wire Guide
Product code: DQX Wire, Guide, Catheter
Reason for recall: Label does not state that the product is heparin-coated.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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
Quantity in commerce: 41,113
Distribution: Nationally
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0960-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0947-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0948-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0949-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0950-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0951-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0952-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0953-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0954-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0955-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0956-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0957-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0958-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0959-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0960-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0961-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0962-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0963-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0964-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0965-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0966-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

Product code DQX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)