Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29334 |
| Brand Name: | Flexor Introducer Sets |
| Model: | Check-Flo Performer® Introducers (RCFW-/-MTS) and Check-Flo® Introducers - Hausdorf-Lock Atrial (RCFW-/-HLA-091100) |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Cook Group Inc |
| Issue: | This new IFU was created to align with that which was cleared in the FDA 510(k) clearance, Submission ID 35803, K171988, Transseptal Introducer and Guide, and in preparation to submit the Technical File covering these devices for approval under EU MDR. There is no change to the manufacturing process, device, or design. This change does not affect the quality, safety, or effectiveness of the device. The Device Description, Intended Use, and Potential Adverse Events sections are all completely new relative to the previous IFU used to cover these devices. The Warnings, Precautions, and Instructions for Use sections have also been updated. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/5/2022 |
