medical Class II Updated 2021-12-22

Cook Inc. recalls Flexor Check-Flo Introducer Ansel Modification Model Numbe

Recalled 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.

Hazard / Issue

Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa

Issued by

FDA

Affected States: AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX, DE
Lot/Code Info: Lot Number: 13895370 UDI: (01)00827002441545(17)240415(10)13895370
View official government recall

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