Z-1714-2022Class II

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN)...

Name: Z-1714-2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN)...
Creator: Cook Incorporated
Published: 2022-07-19
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2022-07-19 / Open, Classified / root cause: packaging

FDA source

Cook Incorporated began a recall of Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange... on 2022-07-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1714-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-19
Posted: 2022-09-09
Recalling firm: Cook Incorporated
Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product code: DQX Wire, Guide, Catheter
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Cook notified consignees by Urgent Medical Device Recall Letter on July 19, 2022. Letter states reason for recall, health risk and action to take: Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected].
Quantity in commerce: 75 units
Distribution: 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
Product codes and lots: UDI-DI: (01)00827002561724- Lot Numbers: 14156569

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1714-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1706-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1707-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1708-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1709-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1710-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1711-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1712-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1713-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1714-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1715-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1716-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1717-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1718-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09

Product code DQX

K110009Class IIRoadrunner Uniglide Hydrophilic Wire GuideCook, Inc. / cleared 2011-02-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)