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Bd alaris large volume pump

Official notice

1 Dec 2022

Last checked

1 Dec 2022

Critical riskHealth Canada
Watch Carefusion 303

An official Health Canada notice concerns Bd alaris large volume pump. BD is recalling the product because if a third-party screw is used, or potentially if the BD manufactured pivot latch screw is reused or improperly installed, it may back out, interfering with door closure, which can lead to over or under infusion. The current BD pivot latch screw design, which was introduced in 2009, includes retaining microspheres that prevent the screw from backing out when properly installed in accordance with labeling. We are notifying customers to ensure that (1) all pivot latch screws are inspected by hospital staff prior to use of lvp, (2) all loose, backed out, and third-party screws are replaced by the hospital biomed staff with new BD manufactured pivot latch screws in accordance with the labeling, and (3) customers are aware of the risks associated with backed-out pivot latch screws. Recall start date: November 15, 2022 Published 2022-12-01.

What to do now

Review/perform action in recall notice, post recall notice on/near device, complete/return reply form.

Recall number

72229

Official notice

2022-12-01

The hazard

BD is recalling the product because if a third-party screw is used, or potentially if the BD manufactured pivot latch screw is reused or improperly installed, it may back out, interfering with door closure, which can lead to over or under infusion. The current BD pivot latch screw design, which was introduced in 2009, includes retaining microspheres that prevent the screw from backing out when properly installed in accordance with labeling. We are notifying customers to ensure that (1) all pivot latch screws are inspected by hospital staff prior to use of lvp, (2) all loose, backed out, and third-party screws are replaced by the hospital biomed staff with new BD manufactured pivot latch screws in accordance with the labeling, and (3) customers are aware of the risks associated with backed-out pivot latch screws. Recall start date: November 15, 2022

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

72229

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Affected products

Product 1

Affected products - BD Alaris Large Volume Pump, Lot or serial number - All lots., Model or catalog number - 8100

Risk / hazard

BD is recalling the product because if a third-party screw is used, or potentially if the BD manufactured pivot latch screw is reused or improperly installed, it may back out, interfering with door closure, which can lead to over or under infusion. The current BD pivot latch screw design, which was introduced in 2009, includes retaining microspheres that prevent the screw from backing out when properly installed in accordance with labeling. We are notifying customers to ensure that (1) all pivot latch screws are inspected by hospital staff prior to use of lvp, (2) all loose, backed out, and third-party screws are replaced by the hospital biomed staff with new BD manufactured pivot latch screws in accordance with the labeling, and (3) customers are aware of the risks associated with backed-out pivot latch screws. Recall start date: November 15, 2022

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Carefusion 303, Bd Alaris Large Volume Pump

Manufacturer

Not provided

Phone

Not provided

Brand: Carefusion 303, Bd Alaris Large Volume Pump.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

72229

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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