Reported Oct 5, 2022 · Ongoing
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146…
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
G00362 | Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 |
G05146 | C-TDOC-18-50-0-2 |
G00364 | TDOC-35-50-0-3 |
G02431 | C-DOC-21-40-0-2 |
G05195 | C-TDOC-21-50-0-2 |
G05145 | C-TDOC-25-50-0-2 |
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 00827002051461Lots/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 2 00827002003644Lots/Expiration Date: 14795065 15-06-2027 TDOC-35-50-0-3 G00364 UDI-DI: 00827002003644 3 00827002024311Lots/Expiration Date: 14802347 20-06-2027 C-DOC-21-40-0-2 G02431 UDI-DI: 00827002024311 4 00827002051959Lots/Expiration Date: NS14795068 15-06-2027 C-TDOC-21-50-0-2 G05195 UDI-DI:00827002051959 5 00827002051454Lots/Expiration Date: NS14802356 20-06-2027 C-TDOC-25-50-0-2 G05145 UDI-DI: 00827002051454 6 Lots/Expiration Date: NS14818384 29-06-2027 NS14818387 29-06-2027 - Amount recalled
- 150 US, 97 OUS
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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