Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 In... — FDA record Z-0388-2022

What the record says

Product

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

Classification

Class II

Recalling firm

Cook Inc.

Quantity

47 units

Agency-reported status

Terminated

Source record identifier

Z-0388-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES, FR, GB,GU, IT, ZA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

• Alabama
• Arizona
• California
• Delaware
• Florida
• Georgia
• Kansas
• Michigan
• Minnesota
• Missouri
• North Carolina
• New York
• Oklahoma
• Texas

Dates in the source

Report date

Dec 22, 2021

Recall initiation date

Nov 12, 2021

Center classification date

Dec 16, 2021

Termination date

Apr 26, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.