Cook Incorporated 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Cook Incorporated
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Cook Incorporated is recalling Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35- due to Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the ste. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026