ICU Medical infusion sets recall in Canada: fluid leak
In plain language
This recall involves Primary PLUM Set, SAPPHIRE Primary Set, and SAPPHIRE Epidural Set infusion sets sold in Canada. They are being recalled because small amounts of fluid may leak from air vents on inline filters. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and lot numbers.
- Contact ICU Medical for return instructions.
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Affected products
Primary PLUM Set, Yellow Striped Tubing, Distal Microbore Tubing, Filter, Secure Lock
Model: 149530489
Lot: 925155H
SAPPHIRE Primary Set
Model: 163350455, 163620455, 163830455
Lot: 3843263, 3849197, 855645H, 855935H, 865495H, 885415H, 896135H, 896195H, 896625H, 936605H
SAPPHIRE Epidural Set
Model: 163730455
Lot: 896225H, 916845H, 925825H, 948155H
Why this matters
Fluid leak
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: 3843263, 3849197, 855645H, 855935H, 865495H, 885415H, 896135H, 896195H, 896625H, 936605H, 896225H, 916845H, 925825H, 948155H, 925155H
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 149530489, 163350455, 163620455, 163730455, 163830455
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?
Fluid leak
What should consumers do?
Stop using the product immediately. Check model and lot numbers. Contact ICU Medical for return instructions.
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. Fluid leak
When was this product recalled?
This product was recalled on August 2, 2019.
Is the ICU Medical brand affected by this recall?
Yes, ICU Medical products are affected by this recall. This recall involves Primary PLUM Set, SAPPHIRE Primary Set, and SAPPHIRE Epidural Set infusion sets sold in Canada. They are being recalled because small amounts of fluid may leak from air vents on inline filters. Stop using the product and follow the return steps in the official notice.