Recall Z-1827-2022 ยท DQX Wire, Guide, Catheter
Cook Incorporated
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)
| Date | Sep 28, 2022 (initiated Aug 16, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235 |
| Quantity | 5571 US, 409 OUS |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171764 | Fixed Core Wire Guides Cook Incorporated, Mar 9, 2018 |