Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6 — Class II medical device recall Z-0387-2022
Terminated recall by Cook Inc., reported 2021-12-22, distributed in AL, AZ, CA, FL, GA, GU, KS, MI…. Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may cont
| Recall number | Z-0387-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2021-11-12 |
| Classified | 2021-12-16 |
| Reported by FDA | 2021-12-22 |
| Terminated | 2024-04-26 |
| Distributed | AL, AZ, CA, FL, GA, GU, KS, MI, MN, MO, NC, NY, OK, TX |
| Quantity | 50 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00827002441545 |
| Lot numbers | 13895370 |
| Model numbers | KCFW-6.0-18/38-45-RB-ANL0-HC |
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.
Reason for recall
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0387-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.