Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)

Class I - Dangerous

🏥 Medical Devices Recalled: August 16, 2022 Cook Incorporated Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
TSFB-35-80 (GPN G01315) UDI-DI 00827002270411 Lots 14751376 Expiration Date 25-05-2027 TSFB-35-145 (GPN G00691) UDI-DI 00827002006911 Lots Expiration Dates 14813687 27-06-2027 14831302 07-07-2027 14831303 07-07-2027 14831304 07-07-2027 14831305 07-07-2027 14831307 07-07-2027 14831308 07-07-2027 14831309 07-07-2027 14831310 07-07-2027 14831311 07-07-2027 14831313 07-07-2027 14842394 14-07-2027 14842395 14-07-2027 14842396 14-07-2027 14842397 14-07-2027 14842398 14-07-2027 14842399 14-07-2027 14842400 14-07-2027 14842401 14-07-2027 TSFB-35-200 (GPN G01095) UDI-DI 00827002010956 Lot/Expiration Date: 14816668 28-06-2027
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Cook Incorporated
Reason for Recall:: 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 I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)

Product Codes/Lot Numbers:

TSFB-35-80 (GPN G01315) UDI-DI 00827002270411 Lots 14751376 Expiration Date 25-05-2027 TSFB-35-145 (GPN G00691) UDI-DI 00827002006911 Lots Expiration Dates 14813687 27-06-2027 14831302 07-07-2027 14831303 07-07-2027 14831304 07-07-2027 14831305 07-07-2027 14831307 07-07-2027 14831308 07-07-2027 14831309 07-07-2027 14831310 07-07-2027 14831311 07-07-2027 14831313 07-07-2027 14842394 14-07-2027 14842395 14-07-2027 14842396 14-07-2027 14842397 14-07-2027 14842398 14-07-2027 14842399 14-07-2027 14842400 14-07-2027 14842401 14-07-2027 TSFB-35-200 (GPN G01095) UDI-DI 00827002010956 Lot/Expiration Date: 14816668 28-06-2027