The Recall Desk
HighFDA (Devices)·Z-1827-2022·Announced 2022-10-05

Bentson Wire Guide Recalled for Packaging Defect Affecting Sterility

Cook Incorporated is recalling Bentson Wire Guide guidewires due to packaging seal failures that may compromise sterility. The recall affects over 5,500 units distributed in the U.S. and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II medical device recall involves an identified packaging seal defect that may compromise sterility. While no illnesses or injuries have been reported, the potential for infection from non-sterile guidewires used in vascular procedures represents a risk-of-harm scenario meeting the criteria for High (score 3) severity per the rubric.

Plain-English summary

Cook Incorporated is recalling Bentson Wire Guide (20cm Distal Flexibility with Softened Tip) guidewires due to a packaging defect. Cook Medical identified that certain device lots may have a complete breach of the chevron seal in the packaging, which may compromise the sterility of the affected devices.

The recall encompasses approximately 5,571 units distributed within the United States and 409 units distributed outside the United States. Multiple product configurations and lot numbers are affected, with expiration dates ranging through July 2027.

Additional information, including specific affected lot numbers, product codes, and manufacturer guidance, is available through the FDA's official recall documentation.

The recalled product

Product
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)
Manufacturer
Cook Incorporated
Category
Medical Device — Guidewire
Hazard
  • sterility-compromise
  • infection-risk

Distribution

Distributed nationwide across the United States.

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