Recall Z-1786-2025 ยท DYB Introducer, Catheter
Cook Incorporated
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
| Date | May 16, 2025 (initiated Apr 17, 2025) |
| Status | Open, Classified |
| Reason | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. |
| Root cause | Under Investigation by firm |
| Action | Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 04/17/2025 via FedEx Standard Overnight. The notice explained the issue, potential risk to health and requested: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledge |
| Quantity | 99 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171999 | Performer Introducer Cook Incorporated, Jul 31, 2017 |