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No image published for this recall

Intraosseous powered drive and needle kits

Official notice

27 Jun 2022

Last checked

27 Jun 2022

Medium riskHealth Canada

An official Health Canada notice concerns Intraosseous powered drive and needle kits. 1. Difficulty separating stylet from needle, which could result in inadvertent removal of the entire needle assembly or inability to remove the stylet from an indwelling intraosseous needle, both resulting in functional loss of intraosseous access. 2. Needle safety mechanism may not deploy as the stylet is removed from the intraosseous needle post placement. 3. Metal discs sticking in power driver, rendering the driver unable to be used Recall start date: June 20, 2022 Published 2022-06-27.

What to do now

Quarantine/ destroy affected inventory, share recall notice with users, return completed response form.

Recall number

64317

Official notice

2022-06-27

The hazard

1. Difficulty separating stylet from needle, which could result in inadvertent removal of the entire needle assembly or inability to remove the stylet from an indwelling intraosseous needle, both resulting in functional loss of intraosseous access. 2. Needle safety mechanism may not deploy as the stylet is removed from the intraosseous needle post placement. 3. Metal discs sticking in power driver, rendering the driver unable to be used Recall start date: June 20, 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

64317

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Affected products

Product 1

Affected products - Intraosseous Powered Driver, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - D001001

Risk / hazard

1. Difficulty separating stylet from needle, which could result in inadvertent removal of the entire needle assembly or inability to remove the stylet from an indwelling intraosseous needle, both resulting in functional loss of intraosseous access. 2. Needle safety mechanism may not deploy as the stylet is removed from the intraosseous needle post placement. 3. Metal discs sticking in power driver, rendering the driver unable to be used Recall start date: June 20, 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: Bard Access, Intraosseous Powered Drive And Needle Kits.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64317

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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