Recall archive / FDA device enforcement
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G017... — FDA record Z-1842-2022
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
- Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
- 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
- 5041 US; 298 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1842-2022
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 | THSCF-35-220-1.5-ROSEN G01623 UDI-DI: 00827002016231 Lots/Expiration Date: 14818344 29-06-2027 14820965 30-06-2027 14849857 20-07-2027 THSCF-35-80-1.5-ROSEN G01774 UDI-DI: 00827002017740 Lots/Expiration Date: 14820960 30-06-2027 14832877 08-07-2027 14847945 19-07-2027 THSCF-35-180-1.5-ROSEN G01264 UDI-DI: 00827002012646 Lots/Expiration Date: 14820961 30-06-2027 14843133 15-07-2027 14847946 19-07-2027 THSCF-35-145-1.5-ROSEN G01261 UDI-DI: 00827002012615 Lots/Expiration Date: 14820962 30-06-2027 14820963 30-06-2027 14820964 30-06-2027 14828587 06-07-2027 14835364 11-07-2027 14835365 11-07-2027 14849859 20-07-2027 |
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.