The Recall Desk
HighFDA (Devices)·Z-1826-2022·Announced 2022-10-05

Bentson Wire Guide Devices Recalled for Potential Sterility Compromise

Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.

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 is an FDA Class II medical device recall for potential sterility compromise due to packaging defect. No illnesses or injuries have been reported, and the hazard is preventive in nature, making it at most a score of 3 per the rubric.

Plain-English summary

Cook Incorporated is recalling certain lots of Bentson Wire Guide guidewires (part number TSMB-35-145, GPN G27041). The devices may have a complete breach of the chevron seal in their packaging, which is designed to protect device sterility.

A breach in the chevron seal may compromise the sterility of the affected devices. Bentson Wire Guide devices are used in medical procedures and are regulated by the FDA as Class II medical devices.

The recalled lot is Lot 14797970 with an expiration date of June 16, 2027. These devices have been distributed domestically nationwide and internationally worldwide.

The recalled product

Product
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
Manufacturer
Cook Incorporated
Category
Medical Device — Surgical / Interventional
Hazard
  • sterility-breach
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • TSMB-35-145 (GPN G27041) UDI-DI 00827002270411
  • Lot 14797970
  • Expiration Date 16-06-2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same category