Cook Incorporated Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874) 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
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
Brand
Cook Incorporated
Lot Codes / Batch Numbers
THSF-35-145-AES-SGH (GPN G06801) - UDI (01)00827002068018(17)270602(10)14767453 - Lot 14767453, Expiration Date 20-06-2027
Products Sold
THSF-35-145-AES-SGH (GPN G06801) - UDI (01)00827002068018(17)270602(10)14767453 - Lot 14767453, Expiration Date 02-06-2027 THSF-38-80-AES-SGH (GPN G06874) - UDI (01)00827002068742(17)270620(10)14802152 - Lot 14802152, Expiration Date 20-06-2027
Cook Incorporated is recalling Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-S 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