Recall Z-0388-2022 ยท DYB Introducer, Catheter
Cook Inc.
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
| Date | Nov 12, 2021 |
| Status | Terminated |
| Reason | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa |
| Root cause | Process control |
| Action | Cook Medical issued Urgent Medical Device Recall letters via mail and/or email to consignees globally. Letter states reason for recall, health risk and action to take: 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 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. Note: Unaffected products that are |
| Quantity | 47 units |
| Distribution | AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES, FR, GB,GU, IT, ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Chec Cook Incorporated, Jul 28, 2015 |