CanadaFlexor® Check‑Flo Introducer and Rösch‑Uchida Transjugular Liver Access Sets from Cook, Incorporated (affected catalogue numbers include KCFW‑9.0‑38‑70‑RB‑RAABE, RUPS‑100 and multiple other KCFW models listed) with lot or serial number “More than 20 numbers, contact manufacturer” are affected. Cook identified these lots may have been manufactured out of specification and may be cut to incorrect length, not correctly trimmed, and/or not inspected properly. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Cook, Incorporated, 750 Daniels Way, Bloomington, Indiana, United States, 47404.
How to identify it
Affected products: Flexor® Check-Flo Introducer-Raabe Modification; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-9.0-38-70-RB-RAABE
Affected products: Flexor® Check-Flo Introducer-Ansel Modification; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-9.0-18/38-45-RB-ANL1-HC
Affected products: Flexor® Check-Flo Introducer-Ansel Modification; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-9.0-18/38-45-RB-ANL0-HC
Affected products: Rösch-Uchida Transjugular Liver Asset Set; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: RUPS-100
Affected products: Flexor® Check-Flo Introducer Set; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-10.0-38-80-RB
Affected products: Flexor® Check-Flo Introducer Set; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-10.0-38-40-RB
Affected products: Flexor® Check-Flo Introducer Set; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-12.0-38-80-RB
Affected products: Flexor® Check-Flo Introducer Set; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-12.0-38-40-RB
Affected products: Flexor® Check-Flo Introducer Set; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-10.0-38-RB
Affected products: Flexor® Check-Flo Introducer-Ansel 1 Modification-With High-Flex Dilator And Hydrophilic Coating; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-10.0-35-45-RB-HFANL1-HC
Affected products: Flexor® Check-Flo Introducer-Ansel 1 Modification-With High-Flex Dilator And Hydrophilic Coating; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-12.0-35-45-RB-HFANL1-HC
Affected products: Flexor® Check-Flo Introducer-Ansel Modification-With Highflex Dilator And Hydrophilic Coating; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-10.0-35-45-RB-HFANL0-HC
Affected products: Flexor® Check-Flo Introducer-Ansel Modification-With Highflex Dilator And Hydrophilic Coating; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-12.0-35-45-RB-HFANL0-HC
Affected products: Flexor® Check-Flo Ii Introducer Set; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: KCFW-9.0-35-38.5-RB-RTPS-100
The hazard
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and/or not inspected properly.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)