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Chemolock port

Official notice

16 Sept 2025

Last checked

16 Sept 2025

Medium riskHealth Canada

An official Health Canada notice concerns Chemolock port. ICU Medical has internally identified a lot-specific issue where the weld of the ChemoLock port was not functioning as intended due to a manufacturing issue. Impacted products include the standalone ChemoLock port, ChemoLock vial adapters, ChemoLock bag spikes, and ChemoLock administration sets that may include the ChemoLock port. The malfunctioning port weld may separate or break during use and potentially result in a leak. Published 2025-09-16.

What to do now

Contact the manufacturer if you require additional information.

Recall number

78071

Official notice

2025-09-16

The hazard

ICU Medical has internally identified a lot-specific issue where the weld of the ChemoLock port was not functioning as intended due to a manufacturing issue. Impacted products include the standalone ChemoLock port, ChemoLock vial adapters, ChemoLock bag spikes, and ChemoLock administration sets that may include the ChemoLock port. The malfunctioning port weld may separate or break during use and potentially result in a leak.

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.

Lots

-specific

Recall Numbers

78071

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Affected products

Product 1

Affected products - Oncology Kit, Lot or serial number - 14397348, Model or catalogue number - CL3360

Product 2

Affected products - Oncology Kit, Lot or serial number - 14369083, Model or catalogue number - CL3967

Product 3

Affected products - Oncology Kit, Lot or serial number - 14386090, Model or catalogue number - CL3967

Product 4

Affected products - Oncology Kit, Lot or serial number - 14391965, Model or catalogue number - CL3967

Product 5

Affected products - Oncology Kit, Lot or serial number - 14369087, Model or catalogue number - CL4188

Product 6

Affected products - Chemolock, Lot or serial number - 14391954, Model or catalogue number - CL3900

Product 7

Affected products - ChemoLock Bag Spike, Lot or serial number - 14419330, Model or catalogue number - CL-10

Product 8

Affected products - ChemoLock Bag Spike, Lot or serial number - 14385224, Model or catalogue number - CL-17

Product 9

Affected products - ChemoLock, Lot or serial number - 14384996, Model or catalogue number - CL-35

Product 10

Affected products - ChemoLock, Lot or serial number - 14391949, Model or catalogue number - CL-35

Product 11

Affected products - ChemoLock, Lot or serial number - 14407070, Model or catalogue number - CL-35

Product 12

Affected products - ChemoLock, Lot or serial number - 14379145, Model or catalogue number - CL2100

Product 13

Affected products - Ext Set W/ChemoLock, Y Connector, Rotating Luer, Lot or serial number - 14414091, Model or catalogue number - CL3950

Product 14

Affected products - Ext Set W/ChemoLock, Y Connector, Rotating Luer, Lot or serial number - 14409213, Model or catalogue number - CL4118

Product 15

Affected products - Ext Set W/ChemoLock, Y Connector, Rotating Luer, Lot or serial number - 14393168, Model or catalogue number - CL3950

Product 16

Affected products - Ext Set W/ChemoLock, Y Connector, Rotating Luer, Lot or serial number - 14393173, Model or catalogue number - CL4118

Product 17

Affected products - ChemoLock Admin Set, Lot or serial number - 14397353, Model or catalogue number - CL3951

Product 18

Affected products - ChemoLock Admin Set, Lot or serial number - 14418912, Model or catalogue number - CL3951

Product 19

Affected products - ChemoLock Vial Spike, Lot or serial number - 14391971, Model or catalogue number - CL-70

Product 20

Affected products - ChemoLock Vial Spike, Lot or serial number - 14395289, Model or catalogue number - CL-70

Product 21

Affected products - ChemoLock Vial Spike, Lot or serial number - 14379176, Model or catalogue number - CL-70S

Product 22

Affected products - ChemoLock Vial Spike, Lot or serial number - 14385352, Model or catalogue number - CL-72

Product 23

Affected products - ChemoLock Vial Spike, Lot or serial number - 14401250, Model or catalogue number - CL-72

Product 24

Affected products - ChemoLock Vial Spike, Lot or serial number - 14391976, Model or catalogue number - CL-80

Product 25

Affected products - ChemoLock Vial Spike, Lot or serial number - 14380121, Model or catalogue number - CL-80S

Product 26

Affected products - ChemoLock Vial Spike, Lot or serial number - 14391979, Model or catalogue number - CL-80S

Product 27

Affected products - ChemoLock Vial Spike, Lot or serial number - 14395313, Model or catalogue number - CL-80S-5

Product 28

Affected products - ChemoLock Vial Spike, Lot or serial number - 14407453, Model or catalogue number - CL-82

Product 29

Affected products - Transfer Set, Lot or serial number - 14376051, Model or catalogue number - CL-33

Product 30

Affected products - Transfer Set, Lot or serial number - 14400613, Model or catalogue number - CL-33

Product 31

Affected products - Transfer Set, Lot or serial number - 14400199, Model or catalogue number - CL-34

Product 32

Affected products - Bag Spike, Clave, Lot or serial number - 14386086, Model or catalogue number - CL3955

Product 33

Affected products - Bag Spike, Clave, Lot or serial number - 14407433, Model or catalogue number - CL3955

Risk / hazard

ICU Medical has internally identified a lot-specific issue where the weld of the ChemoLock port was not functioning as intended due to a manufacturing issue. Impacted products include the standalone ChemoLock port, ChemoLock vial adapters, ChemoLock bag spikes, and ChemoLock administration sets that may include the ChemoLock port. The malfunctioning port weld may separate or break during use and potentially result in a leak.

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: Icu Medical Canada, Chemolock Port.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

78071

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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