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Double Flexible Tipped Wire Guide, Guidewire recallZ-1831-2022 · Cook Incorporated · initiated Aug 16, 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

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-1831-2022
Status
Open, Classified
Initiated by the company
Aug 16, 2022
Posted by the FDA
Sep 28, 2022
Recalling firm
Cook Incorporated
Quantity
150 US, 97 OUS
Product code
DQX
FDA submissions
K181351, K171912
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.

Product description

Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145

Code information (models, lots, serial numbers)

TDOC-35-145-0-3 G00362 UDI-DI: 00827002003620 Lots/Expiration Date: 14793053 14-06-2027 14797769 16-06-2027 14802346 20-06-2027 14802348 20-06-2027 14812034 24-06-2027 C-TDOC-18-50-0-2 G05146 UDI-DI: 00827002051461 Lots/Expiration Date: 14795065 15-06-2027 TDOC-35-50-0-3 G00364 UDI-DI: 00827002003644 Lots/Expiration Date: 14802347 20-06-2027 C-DOC-21-40-0-2 G02431 UDI-DI: 00827002024311 Lots/Expiration Date: NS14795068 15-06-2027 C-TDOC-21-50-0-2 G05195 UDI-DI:00827002051959 Lots/Expiration Date: NS14802356 20-06-2027 C-TDOC-25-50-0-2 G05145 UDI-DI: 00827002051454 Lots/Expiration Date: NS14818384 29-06-2027 NS14818387 29-06-2027

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 90793).

Sources and updates

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