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Affinity fusion oxygenators

Official notice

4 Jan 2023

Last checked

4 Jan 2023

Medium riskHealth Canada

An official Health Canada notice concerns Affinity fusion oxygenators. Loose Temperature Monitoring Adapter (TMA) located on the Affinity Fusion Oxygenator either during pre-procedure perfusion set up or post-procedure when disassembling the perfusion circuit. Recall start date: December 12, 2022 Published 2023-01-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72505

Official notice

2023-01-04

The hazard

Loose Temperature Monitoring Adapter (TMA) located on the Affinity Fusion Oxygenator either during pre-procedure perfusion set up or post-procedure when disassembling the perfusion circuit. Recall start date: December 12, 2022

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

72505

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Affected products

Product 1

Affected products - Intersept Custom Tubing Packs, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - HY9G02R4 HY9M73R2 HY8H57R16

Product 2

Affected products - Custom Pack W/Bb Coating, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - BB8B22R15 BB8B22R14

Product 3

Affected products - Intersept Custom Tubing Packs With Cortiva, Lot or serial number - 224879055 224277409 224033614 223282965, Model or catalog number - HY11M41R1 M020517G

Risk / hazard

Loose Temperature Monitoring Adapter (TMA) located on the Affinity Fusion Oxygenator either during pre-procedure perfusion set up or post-procedure when disassembling the perfusion circuit. Recall start date: December 12, 2022

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic, Affinity Fusion Oxygenators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

72505

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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