Recall MonitorHealth Products
Flexor® Check-Flo Introducer and Rösch-Uchida Transjugular Liver Access Sets
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular, Health products - Medical devices - General and plastic surgery
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
Recall class: Type II
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.