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Roadrunner UniGlide recallZ-1717-2022 · Cook Incorporated · initiated Jul 19, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cook Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

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].

Recall details

Recall number
Z-1717-2022
Status
Open, Classified
Initiated by the company
Jul 19, 2022
Recalling firm
Cook Incorporated
Quantity
30 units
Product code
DQX
FDA submissions
K110009
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 description

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Code information (models, lots, serial numbers)

UDI-DI: (01)00827002561526- Lot Numbers: 14118842

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 90710).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page