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Lower risk Medical device recall · FDA · Published October 13, 2017

Cook Coons Interventional Wire Guide Recall: Heparin Coating Missing

Cook recalls Coons Interventional Wire Guides with heparin coating not labeled. Affected units have specific lot codes. Contact for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0954-2018Medical deviceCook ›
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Contact the company

Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
✎ GovInfoNow plain-language explainer

Cook is recalling Coons Interventional Wire Guides because the product label does not state it is heparin-coated. This could lead to improper use if the coating is needed for blood thinning during medical procedures. Read more at govinfonow.com/recall/72841-cook-coons-interventional-wire-guide-recall-heparin-coating-missing.

Source Summary by GovInfoNow · govinfonow.com/recall/72841-cook-coons-interventional-wire-guide-recall-heparin-coating-missing · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0954-2018

Cite this page

“Cook Coons Interventional Wire Guide Recall: Heparin Coating Missing.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72841-cook-coons-interventional-wire-guide-recall-heparin-coating-missing. Based on FDA recall #Z-0954-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0954-2018%22&limit=1).

The FDA announced on 2017-10-13 that Cook Inc. voluntarily recalled its Coons Interventional Wire Guide because the label fails to state the product is heparin-coated. The agency issued recall number Z-0954-2018 for the Class II device.

How to tell if you have it

  • Brand: Cook
  • Product: Coons Interventional Wire Guide
  • Catalog #: THSF-/-COONS-BH
  • Lot codes: 3730001 - 6164916, F3729969 - F4922979, NS4928020 - NS6203182

The hazard

The hazard is that the label does not state that the product is heparin-coated. The record provides no information regarding incidents or injuries.

Context

GovInfoNow's records show Cook Inc. has 38 other recalls on record since 2017-07-31. Other recent recalls of similar products include Cook Flexor Check-Flo Introducer Ansel Modification (2021-11-12), Cook Skinny Needle with Chiba Tip Recall (2021-10-13), and Cook Transseptal Needle Recall (2021-10-08). Additional similar product recalls include Cook Medical Approach CTO-18 Micro Wire Guide Recall (2026-03-05), Cook Ring Transjugular Intrahepatic Access Sets Recall (2025-11-26), and Cook Medical Approach CTO-12 Micro Wire Guide (2026-03-05).

How to tell if you have this one

Check the product label for the lot code. Affected units have specific lot codes: 37300: 6164916, F3729969 - F4922979, NS4928020 - NS6203182.

  • Brand
    Cook
  • Category
    Medical device
FDA recall event · 20 products

All 20 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationally
Recall numberProduct, codes & lotsQuantity
Z-0947-2018Amplatz Extra Stiff Whisker Wire Guide; Catalog # THSCF-35-260-3-AESW-BH Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894648
Z-0948-2018Amplatz Extra Stiff Wire Guide; Catalog # THSCF / AES-BH THSF / AES-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894129,727
Z-0949-2018Amplatz Stiff Wire Guide; Catalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS620318232,340
Z-0950-2018Amplatz Ultra Stiff Wire Guide; 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 - NS617789412,462
Z-0951-2018Bentson Cerebral Wire Guide; Catalog # THSFB-35-145-BH Affected lots to include: F3813488 - F4859795 NS5327890 - NS606029145
Z-0952-2018Bentson Plus Wire Guide; Catalog # TSFBP- / -BH Affected lots include: 3771080 - 5942053 F42656398,147
Z-0953-2018Bentson Wire Guide; Catalog # TSFB-/-BH Affected lots include: F3813488 - F4859795 NS5327890 - NS6060291 3730884 - 5984142 F3746894 - F4920488 NS4937520 - NS6252870439,797
Z-0954-2018Coons Interventional Wire Guide; Catalog # THSF-/-COONS-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS62031823,369
Z-0955-2018Disposable Reuter Tip Deflecting Wire Guide; Catalog # DTDW-/-BW Affected lots to include: 3730008 - 6164931 F4374635 - F4791430 NS5034700 - NS556294718,398
Z-0956-2018Double Flexible Tipped Wire Guide; Catalog # DTDW-/-BW Affected lots include: F3749839 - F4849938 NS5085893 - NS5827127 F4628078 - F4856722 3763189 - 6106860 F3739663 - F4916737 NS4980257 - NS609899010,367
Z-0957-2018Fixed Core Bentson; Catalog # TSCFB-/-BH Affected lots range from: F3734676 - F4911986 NS4938980 - NS61440782,210
Z-0958-2018Fixed Core Wire Guide; Catalog # C-SCF-/-BH C-SF-/-BH SF-/-BH THSCF-/-BH THSF-/-BH TSCF-/-BH TSCFR-/-BH TSF-/-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894 F3753452 - F4925547 NS5008794 - NS6171324 F3922830 - F4218188 NS5470403 - NS6020850 F4087814 - F4741344 NS4929840 - NS5104065 F4119548 - F4920483 NS5171771 - NS6144080 3730875 - 6180567 F3730082 - F4924418 NS4928022 - NS6177724 NS5185993 3730101 - 6181269 F3734860 - F4923958 NS4927349 - NS6203187601,778
Z-0959-2018Movable Core Wire Guide; Catalog # TCMTNA-/-BH TMT-/-BH TSFNA-/-BH Affected lots range from: 3774481 - 6145673 F3876320 - F4894841 NS4963396 - NS5144675 F4608907 3758468 - 616781421,913
Z-0960-2018Newton Wire Guide; 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 - NS596318041,113
Z-0961-2018Reuter Tip Deflecting Wire Guide; Catalog # TDW-/-SGH-BH Affected lots to include: F4423853 - F4898351 NS5072022 - NS616676455
Z-0962-2018Rosen Curved Wire Guide; Catalog # TDW-/-SGH-BH Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS617789498,502
Z-0963-2018TFE Coated Curved Newton LLT; Catalog # TSCFNB-35-180-SPENCERMOD- BH Affected lots to include: 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS59631803,364
Z-0964-2018Central Venous Catheter Tray; Catalog # TSCFNB-35-180-SPENCERMOD- BH ALL LOTS13
Z-0965-2018Left Atrial Catheter Set; Catalog # C-ULAP-5.0-60-DTK-BH ALL LOTS56
Z-0966-2018Femoral Artery Pressure Monitoring Set; Catalog # C-PMS-300-CHILDRENS-A- 032988 ALL LOTS266
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the lot code on the label to determine if the product is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationally” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Oct 13, 201712. FDA classified it Class II: Mar 9, 201823. Published in FDA’s Enforcement Report: Mar 21, 201834. FDA terminated the recall: Oct 23, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0954-2018 (October 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0954-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA