The Recall Desk
HighFDA (Devices)·Z-1825-2022·Announced 2022-10-05

Bentson Plus Guidewire Recall for Compromised Packaging Sterility Seal

Cook Incorporated is recalling Bentson Plus Wire Guides due to potential packaging seal breaches that may compromise device sterility. Affected devices may not maintain proper sterility before use.

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 FDA Class II medical device recall involves a sterility compromise where the packaging may be breached before use. Although no illnesses or injuries have been reported, compromised sterility of a medical device represents a risk-of-harm to patients, meeting the rubric criterion for High severity.

Plain-English summary

Cook Incorporated is recalling certain lots of Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip) due to a potential complete breach of the chevron seal on the packaging.

The packaging breach may compromise the sterility of the affected devices. If the sterile barrier is breached before use, the device may not be safe for clinical use in interventional procedures.

The recall affects 488 units distributed throughout the United States and 5 units distributed internationally. The affected guidewires include two model types: TSFBP-35-180 (part number G09782) and TSFBP-35-145 (part number G09735), with multiple specific lot numbers identified by Cook Incorporated.

Healthcare providers and facilities that have received affected devices should stop using them immediately and contact Cook Incorporated. Device users should review their inventory against the affected lot numbers and dispose of recalled units according to facility protocols. For questions about the recall, contact Cook Incorporated or the FDA.

The recalled product

Product
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
Manufacturer
Cook Incorporated
Category
Medical Device — Guidewire / Interventional
Hazard
  • sterile-barrier-breach
  • sterility-compromise

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 (4)

  • TSFBP-35-180 (GPN G09782) UDI-DI 00827002097827
  • Lots 14797763 14797770 14805076 14805079 14813709 14813711
  • TSFBP-35-145 (GPN G09735) UDI-DI 00827002097353
  • Lots 14807595 14812037 14812038

Distribution

Distributed nationwide across the United States.

Related recalls

Same category