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Roadrunner recallZ-1840-2022 · Cook Incorporated · initiated Aug 16, 2022

Class II Open, Classified All recalls posted in September 2022

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

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDA root cause category: Under Investigation by firm

What the company is doing

On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235

Recall details

Recall number
Z-1840-2022
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 16, 2022
Posted by the FDA
Sep 28, 2022
Recalling firm
Cook Incorporated
Quantity
115 US
Product code
DQX
FDA submissions
K182985
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.

Product description

Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866

Code information (models, lots, serial numbers)

RLPC-35-145 G06866 UDI-DI: 00827002068667 Lots/Expiration Date: 14828631 06-07-2025 14828643 06-07-2025 14828644 06-07-2025

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 90793).

Sources and updates

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