Device product
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Z-0387-2022
Product summary
- Firm
- Cook Inc.
- Event
- Event 89072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-0387-2022
Official wording
Reason: Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Code information: Lot Number: 13895370 UDI: (01)00827002441545(17)240415(10)13895370
Distribution pattern: AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES, FR, GB,GU, IT, ZA
Derived failure modes
-
Labeling or packaging
mislabeled