No image published for this recall

No image published for this recall

Tamper evident additive port cap

Official notice

13 Nov 2025

Last checked

13 Nov 2025

Medium riskHealth Canada

An official Health Canada notice concerns Tamper evident additive port cap. The recall was initiated by IMI following their internal discovery that the corrugated shipper box contains incorrect compatibility information. All other information on the box label is correct, including the device label and IFU. Users are advised to not discard or return the device as it is safe to use, and to verify compatibility using the device label and IFU, not the shipper box. Published 2025-11-13.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81213

Official notice

2025-11-13

The hazard

The recall was initiated by IMI following their internal discovery that the corrugated shipper box contains incorrect compatibility information. All other information on the box label is correct, including the device label and IFU. Users are advised to not discard or return the device as it is safe to use, and to verify compatibility using the device label and IFU, not the shipper box.

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

81213

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Affected products

Product 1

Affected products - Tamper Evident Additive Port Cap, Lot or serial number - 58203, Model or catalogue number - 21-01

Product 2

Affected products - Tamper Evident Additive Port Cap, Lot or serial number - 58590, Model or catalogue number - 21-01

Product 3

Affected products - Tamper Evident Additive Port Cap, Lot or serial number - 57325, Model or catalogue number - 21-01

Product 4

Affected products - Tamper Evident Additive Port Cap, Lot or serial number - 56586, Model or catalogue number - 21-01

Risk / hazard

The recall was initiated by IMI following their internal discovery that the corrugated shipper box contains incorrect compatibility information. All other information on the box label is correct, including the device label and IFU. Users are advised to not discard or return the device as it is safe to use, and to verify compatibility using the device label and IFU, not the shipper box.

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: Medical, Tamper Evident Additive Port Cap.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81213

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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