Flexor® Check-Flo Introducer and Rösch-Uchida Transjugular Liver Access Sets
Brand(s)
Last updated
Summary
Product
Flexor® Check-Flo Introducer and Rösch-Uchida Transjugular Liver Access Sets
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Flexor® Check-Flo Introducer-Raabe Modification | More than 20 numbers, contact manufacturer. | KCFW-9.0-38-70-RB-RAABE |
| Flexor® Check-Flo Introducer-Ansel Modification | More than 20 numbers, contact manufacturer. | KCFW-9.0-18/38-45-RB-ANL1-HC |
| Flexor® Check-Flo Introducer-Ansel Modification | More than 20 numbers, contact manufacturer. | KCFW-9.0-18/38-45-RB-ANL0-HC |
| Rösch-Uchida Transjugular Liver Asset Set | More than 20 numbers, contact manufacturer. | RUPS-100 |
| Flexor® Check-Flo Introducer Set | More than 20 numbers, contact manufacturer. | KCFW-10.0-38-80-RB |
| Flexor® Check-Flo Introducer Set | More than 20 numbers, contact manufacturer. | KCFW-10.0-38-40-RB |
| Flexor® Check-Flo Introducer Set | More than 20 numbers, contact manufacturer. | KCFW-12.0-38-80-RB |
| Flexor® Check-Flo Introducer Set | More than 20 numbers, contact manufacturer. | KCFW-12.0-38-40-RB |
| Flexor® Check-Flo Introducer Set | More than 20 numbers, contact manufacturer. | KCFW-10.0-38-RB |
| Flexor® Check-Flo Introducer-Ansel 1 Modification-With High-Flex Dilator And Hydrophilic Coating | More than 20 numbers, contact manufacturer. | KCFW-10.0-35-45-RB-HFANL1-HC |
| Flexor® Check-Flo Introducer-Ansel 1 Modification-With High-Flex Dilator And Hydrophilic Coating | More than 20 numbers, contact manufacturer. | KCFW-12.0-35-45-RB-HFANL1-HC |
| Flexor® Check-Flo Introducer-Ansel Modification-With Highflex Dilator And Hydrophilic Coating | More than 20 numbers, contact manufacturer. | KCFW-10.0-35-45-RB-HFANL0-HC |
| Flexor® Check-Flo Introducer-Ansel Modification-With Highflex Dilator And Hydrophilic Coating | More than 20 numbers, contact manufacturer. | KCFW-12.0-35-45-RB-HFANL0-HC |
| Flexor® Check-Flo Ii Introducer Set | More than 20 numbers, contact manufacturer. | KCFW-9.0-35-38.5-RB-RTPS-100 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - General and plastic surgery
Companies
Cook, Incorporated
750 Daniels Way, Bloomington, Indiana, United States, 47404
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81316
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