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)
Reported: October 5, 2022 Initiated: August 16, 2022 #Z-1827-2022
Product 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)
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.
Details
- Recalling Firm
- Cook Incorporated
- Units Affected
- 5571 US, 409 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Cook Incorporated. Units affected: 5571 US, 409 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-1827-2022.
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