Recall Z-0045-2025 ยท DYB Introducer, Catheter
Cook Incorporated
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
| Date | Oct 9, 2024 (initiated Sep 16, 2024) |
| Status | Open, Classified |
| Reason | Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect. |
| Root cause | Process control |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated 9/13/24 was sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product s from the lot listed above. If so, quarantine any affected products that remain unused. Immediately cease all further distribution and use o f 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 Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowl |
| Quantity | 50 units |
| Distribution | International distribution to the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171999 | Performer Introducer Cook Incorporated, Jul 31, 2017 |