FDA Device recall Z-0387-2022
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce th…
- FDA Device
- Class II
- terminated
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce th… by Cook, citing flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0387-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-12 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook |
| Distribution | AL, AZ, CA, DE, FL, GA, KS, MI, MN, MO, NC, NY, OK, TX |
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
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Identifiers
| code_info | Lot Number: 13895370 UDI: (01)00827002441545(17)240415(10)13895370 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0387-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.