Cook Inc.: Medical Device Recall in 2021 - (Recall #: Z-0387-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 12, 2021

Date Posted: December 22, 2021

Recall Number: Z-0387-2022

Event ID: 89072

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

Status: Terminated

Product Quantity: 50 units

Code Information:

Lot Number: 13895370 UDI: (01)00827002441545(17)240415(10)13895370

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

Voluntary or Mandated:

Voluntary: Firm initiated