FDA Enforcement
Class II
Terminated
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.
Recall: Z-0388-2022
·
Reported December 22, 2021
Enforcement
- Recall Number
- Z-0388-2022
- Event ID
- 89072
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cook Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 22, 2021
- Initiation Date
- November 12, 2021
- Classification Date
- December 16, 2021
- Termination Date
- April 26, 2024
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120, United States
Description
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.
Reason
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Code Info
Lot Number: 13911710 UDI: (01)00827002441552(17)240422(10)13911710
Distribution
AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES, FR, GB,GU, IT, ZA
Quantity
47 units