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Palindrome mahurkar chronic catheter

Official notice

20 Jun 2022

Last checked

20 Jun 2022

Medium riskHealth Canada

An official Health Canada notice concerns Palindrome mahurkar chronic catheter. Medtronic has identified a potential leaking condition within the hub of specific chronic hemodialysis catheters. Flushing one extension tube may result in unanticipated fluid return through the adjacent extension tube (in addition to the anticipated flow of fluid through the distal tip of the catheter). The condition is the result of an inter-lumen void formed in the hub component of the catheter during the manufacturing process. During use, this observed condition could translate to cross-communication of the blood circuit. Recall start date: June 9, 2022 Published 2022-06-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64286

Official notice

2022-06-20

The hazard

Medtronic has identified a potential leaking condition within the hub of specific chronic hemodialysis catheters. Flushing one extension tube may result in unanticipated fluid return through the adjacent extension tube (in addition to the anticipated flow of fluid through the distal tip of the catheter). The condition is the result of an inter-lumen void formed in the hub component of the catheter during the manufacturing process. During use, this observed condition could translate to cross-communication of the blood circuit. Recall start date: June 9, 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

64286

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Affected products

Product 1

Affected products - Palindrome Precision Si Chronic Catheter, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8888119368 8888123408

Product 2

Affected products - Mahurkar Chronic Carbothane Catheters, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8888145028 8888145027

Product 3

Affected products - Palindrome Precision Hsi Chronic Catheter, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8888133509 8888119369

Product 4

Affected products - Mahurkar Chronic Carbothane Catheters, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8888119362

Risk / hazard

Medtronic has identified a potential leaking condition within the hub of specific chronic hemodialysis catheters. Flushing one extension tube may result in unanticipated fluid return through the adjacent extension tube (in addition to the anticipated flow of fluid through the distal tip of the catheter). The condition is the result of an inter-lumen void formed in the hub component of the catheter during the manufacturing process. During use, this observed condition could translate to cross-communication of the blood circuit. Recall start date: June 9, 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: Covidien, Palindrome Mahurkar Chronic Catheter.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64286

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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