Recall archive / FDA device enforcement
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146... — FDA record Z-1831-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Cook Incorporated
- Quantity
- 150 US, 97 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1831-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 5, 2022
- Recall initiation date
- Aug 16, 2022
- Center classification date
- Sep 28, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.