Z-0387-2022 Class II Terminated
FDA device recall Z-0387-2022 was initiated by Cook Inc. on Nov 12, 2021 and is designated Class II. 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 The recall status is terminated (terminated Apr 26, 2024). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 22, 2021
- Initiation Date
- Nov 12, 2021
- Termination Date
- Apr 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
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
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
Code Information
Lot Number: 13895370 UDI: (01)00827002441545(17)240415(10)13895370
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0387-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026