CLASS II ONGOING Device recall · Reported 21 Sep 2022 · FDA Enforcement Report

Roadrunner UniGlide Hydrophilic Wire Guide Reference recalled

Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guide Reference, distributed nationwide in the US. The recall was initiated on 19 Jul 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: (01)00827002561625- Lot Numbers: 14070920, 14174878

Quantity recalled35 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1712-2022
FDA event ID: 90710
Recalling firm: Cook Incorporated, Bloomington, IN
Classification: Class II
Status: Ongoing
Recall initiated: 19 Jul 2022
FDA classified: 9 Sep 2022
Reported: 21 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

19 Jul 2022	Recall initiated by company
9 Sep 2022	Classified by FDA	+52 days
21 Sep 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Where it was distributed

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

Nationwide Arkansas California Illinois North Carolina Puerto Rico

Questions about this recall

Is Roadrunner UniGlide Hydrophilic Wire Guide Reference recalled?

Yes. Cook Incorporated recalled Roadrunner UniGlide Hydrophilic Wire Guide Reference on 19 Jul 2022. The recall is Class II and its status is Ongoing. Recall number Z-1712-2022.

Why was it recalled?

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Which lots are affected?

UDI-DI: (01)00827002561625- Lot Numbers: 14070920, 14174878

Where was it sold?

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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