ChemoLock Port recall in Canada: medical device performance issue
In plain language
This recall involves various ChemoLock Port medical devices sold in Canada. They are being recalled because a manufacturing issue may cause the port weld to separate or break, potentially leading to a leak. Healthcare professionals should stop using the affected products and contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Check the model and lot numbers of your ChemoLock Port devices.
- Contact ICU Medical Canada, Inc. for additional information.
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Affected products
Oncology Kit
Model: CL3360, CL3967, CL4188
Lot: 14369083, 14369087, 14386090, 14391965, 14397348
Chemolock
Model: CL3900
Lot: 14391954
ChemoLock Bag Spike
Model: CL-10, CL-17
Lot: 14385224, 14419330
ChemoLock
Model: CL-35, CL2100
Lot: 14379145, 14384996, 14391949, 14407070
Ext Set W/ChemoLock, Y Connector, Rotating Luer
Model: CL3950, CL4118
Lot: 14393168, 14393173, 14409213, 14414091
ChemoLock Admin Set
Model: CL3951
Lot: 14397353, 14418912
ChemoLock Vial Spike
Model: CL-70, CL-70S, CL-72, CL-80, CL-80S, CL-80S-5, CL-82
Lot: 14379176, 14380121, 14385352, 14391971, 14391976, 14391979, 14395289, 14395313, 14401250, 14407453
Transfer Set
Model: CL-33, CL-34
Lot: 14376051, 14400199, 14400613
Bag Spike, Clave
Model: CL3955
Lot: 14386086, 14407433
Why this matters
Medical device performance issue
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 14369083, 14369087, 14376051, 14379145, 14379176, 14380121, 14384996, 14385224, 14385352, 14386086, 14386090, 14391949, 14391954, 14391965, 14391971, 14391976, 14391979, 14393168, 14393173, 14395289, 14395313, 14397348, 14397353, 14400199, 14400613, 14401250, 14407070, 14407433, 14407453, 14409213, 14414091, 14418912, 14419330
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: CL-10, CL-17, CL-33, CL-34, CL-35, CL-70, CL-70S, CL-72, CL-80, CL-80S, CL-80S-5, CL-82, CL2100, CL3360, CL3900, CL3950, CL3951, CL3955, CL3967, CL4118, CL4188
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Medical device performance issue
What should consumers do?
Stop using the product immediately. Check the model and lot numbers of your ChemoLock Port devices. Contact ICU Medical Canada, Inc. for additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Medical device performance issue
When was this product recalled?
This product was recalled on September 16, 2025.
Is the Icu Medical Canada, Inc. brand affected by this recall?
Yes, Icu Medical Canada, Inc. products are affected by this recall. This recall involves various ChemoLock Port medical devices sold in Canada. They are being recalled because a manufacturing issue may cause the port weld to separate or break, potentially leading to a leak. Healthcare professionals should stop using the affected products and contact the manufacturer for more information.