Quick summary
Quick summary: Flexor® Check-Flo Introducer and Rösch-Uchida Transjugular Liver Access Sets. Date: 2025-12-03.
Public recall detail
Flexor® Check-Flo Introducer and Rösch-Uchida Transjugular Liver Access Sets
2025-12-03
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Flexor® Check-Flo Introducer and Rösch-Uchida Transjugular Liver Access Sets. Date: 2025-12-03.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandCook, Incorporated
ProductFlexor® Check-Flo Introducer and Rösch-Uchida Transjugular Liver Access Sets
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81316
Affected products
ProductFlexor® Check-Flo Introducer-Raabe Modification
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-9.0-38-70-RB-RAABE
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer-Raabe Modification
ProductFlexor® Check-Flo Introducer-Ansel Modification
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-9.0-18/38-45-RB-ANL1-HC
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer-Ansel Modification
ProductFlexor® Check-Flo Introducer-Ansel Modification
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-9.0-18/38-45-RB-ANL0-HC
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer-Ansel Modification
ProductRösch-Uchida Transjugular Liver Asset Set
LotMore than 20 numbers, contact manufacturer.
ModelRUPS-100
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionRösch-Uchida Transjugular Liver Asset Set
ProductFlexor® Check-Flo Introducer Set
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-10.0-38-80-RB
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer Set
ProductFlexor® Check-Flo Introducer Set
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-10.0-38-40-RB
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer Set
ProductFlexor® Check-Flo Introducer Set
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-12.0-38-80-RB
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer Set
ProductFlexor® Check-Flo Introducer Set
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-12.0-38-40-RB
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer Set
ProductFlexor® Check-Flo Introducer Set
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-10.0-38-RB
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer Set
ProductFlexor® Check-Flo Introducer-Ansel 1 Modification-With High-Flex Dilator And Hydrophilic Coating
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-10.0-35-45-RB-HFANL1-HC
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer-Ansel 1 Modification-With High-Flex Dilator And Hydrophilic Coating
ProductFlexor® Check-Flo Introducer-Ansel 1 Modification-With High-Flex Dilator And Hydrophilic Coating
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-12.0-35-45-RB-HFANL1-HC
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer-Ansel 1 Modification-With High-Flex Dilator And Hydrophilic Coating
ProductFlexor® Check-Flo Introducer-Ansel Modification-With Highflex Dilator And Hydrophilic Coating
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-10.0-35-45-RB-HFANL0-HC
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer-Ansel Modification-With Highflex Dilator And Hydrophilic Coating
ProductFlexor® Check-Flo Introducer-Ansel Modification-With Highflex Dilator And Hydrophilic Coating
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-12.0-35-45-RB-HFANL0-HC
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Introducer-Ansel Modification-With Highflex Dilator And Hydrophilic Coating
ProductFlexor® Check-Flo Ii Introducer Set
LotMore than 20 numbers, contact manufacturer.
ModelKCFW-9.0-35-38.5-RB-RTPS-100
Serial numberMore than 20 numbers, contact manufacturer.
DescriptionFlexor® Check-Flo Ii Introducer Set
Issue
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 you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular Health products - Medical devices - General and plastic surgery
CompaniesCook, Incorporated 750 Daniels Way, Bloomington, Indiana, United States, 47404
Recall date2025-11-26
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81316
Background{}
CompaniesCook, Incorporated 750 Daniels Way, Bloomington, Indiana, United States, 47404
AudiencesHealthcare
Source updated2025-12-03
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
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