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Cadd-solis™ ambulatory infusion pump

Official notice

28 Apr 2025

Last checked

28 Apr 2025

Medium riskHealth Canada

An official Health Canada notice concerns Cadd-solis™ ambulatory infusion pump. Under certain conditions, a CADD-Solis™ pump may trigger an erroneous (false) upstream occlusion (USO) alarm. The erroneous USO alarm may occur when there is a delay of more than one hour between the first prime or infusion of a new CADD administration set and the next prime or infusion of the same CADD administration set. The USO alarm is a high priority alarm that will interrupt an ongoing infusion or delay initiation of an infusion. The pump cannot resume or start an infusion until the alarm is cleared. A USO alarm may potentially occur if all these conditions are met: using a CADD administration set (i.e. Not a medication cassette reservoir), and enabling the upstream occlusion alarm, and not programming keep vein open (KVO) or continuous rate, and priming or infusing shortly after attaching the administration set and the next infusion does not occur for approximately one hour or longer. This issue will not occur when using a medication cassette reservoir, if the USO alarm is disabled, if the KVO setting is programmed, or if a continuous rate setting is programmed. Recall start date: April 8, 2025 Published 2025-04-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77346

Official notice

2025-04-28

The hazard

Under certain conditions, a CADD-Solis™ pump may trigger an erroneous (false) upstream occlusion (USO) alarm. The erroneous USO alarm may occur when there is a delay of more than one hour between the first prime or infusion of a new CADD administration set and the next prime or infusion of the same CADD administration set. The USO alarm is a high priority alarm that will interrupt an ongoing infusion or delay initiation of an infusion. The pump cannot resume or start an infusion until the alarm is cleared. A USO alarm may potentially occur if all these conditions are met: using a CADD administration set (i.e. Not a medication cassette reservoir), and enabling the upstream occlusion alarm, and not programming keep vein open (KVO) or continuous rate, and priming or infusing shortly after attaching the administration set and the next infusion does not occur for approximately one hour or longer. This issue will not occur when using a medication cassette reservoir, if the USO alarm is disabled, if the KVO setting is programmed, or if a continuous rate setting is programmed. Recall start date: April 8, 2025

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

77346

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Affected products

Product 1

Affected products - CADD-Solis™ Ambulatory Infusion Pump, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 21-2101-0200-02 21-2111-0403-78 21-2112-0400-51 21-2112-0401-51 21-2112-0403-78 21-2102-51 21-2111-0100-51 21-2111-0300-00 21-2111-0400-51 21-2111-0401-51 21-2111-0403-51 21-2112-0200-02 21-2112-0300-50 21-2112-0403-02 21-2112-0403-51 21-2111-0300-02 21-2112-0300-02 21-2111-0300-50 21-2112-0100-51 21-2111-0403-02 21-2101-51 21-2111-0200-02

Product 2

Affected products - CADD-Solis VIP™ Ambulatory Infusion Pump, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 21-2120-0100-95 21-2120-0103-02 21-2120-0100-50 21-2120-0102-92 21-2120-0103-51 21-2120-0102-51 21-2120-0100-02 21-2120-0102 -02 21-2120-0102-78 21-2120-0103-78 21-2120-0100-51

Risk / hazard

Under certain conditions, a CADD-Solis™ pump may trigger an erroneous (false) upstream occlusion (USO) alarm. The erroneous USO alarm may occur when there is a delay of more than one hour between the first prime or infusion of a new CADD administration set and the next prime or infusion of the same CADD administration set. The USO alarm is a high priority alarm that will interrupt an ongoing infusion or delay initiation of an infusion. The pump cannot resume or start an infusion until the alarm is cleared. A USO alarm may potentially occur if all these conditions are met: using a CADD administration set (i.e. Not a medication cassette reservoir), and enabling the upstream occlusion alarm, and not programming keep vein open (KVO) or continuous rate, and priming or infusing shortly after attaching the administration set and the next infusion does not occur for approximately one hour or longer. This issue will not occur when using a medication cassette reservoir, if the USO alarm is disabled, if the KVO setting is programmed, or if a continuous rate setting is programmed. Recall start date: April 8, 2025

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: Smiths Medical Asd, Cadd-solis™ Ambulatory Infusion Pump.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77346

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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