Recall Z-1827-2022— Cook Incorporated
Class II · Ongoing
Class II FDA medical device recall by Cook Incorporated, initiated 2022-08-16. It names one FDA 510(k) clearance: K171764. 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). Reason: 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..
- Recalling firm
- Cook Incorporated
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-16
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.