LEVEL 1® Fluid Warming Systems recall in Canada: aluminum leaching
In plain language
This recall involves LEVEL 1® Fast Flow and Irrigation Fluid Warming Systems sold in Canada. They are being recalled because they may leach aluminum. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Smiths Medical ASD, Inc. for more information.
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Affected products
Fluid warming systems and compressors
Model: H-1000
Lot: More than 10 numbers, contact manufacturer.
LEVEL 1 NORMOFLO IRRIGATION WARMING SETS (DISPOSABLE)
Model: IR-40, IR-500, IR-600
Lot: More than 10 numbers, contact manufacturer.
NORMOFLO IRRIGATION FLUID WARMER
Model: H-1129, H1100
Lot: More than 10 numbers, contact manufacturer.
FLUID WARMING SYSTEM W/TWO PRESSURE INFUSERS/BUILD IN AIR DETECTOR CLAMP
Model: H-1200-EN-115V
Lot: More than 10 numbers, contact manufacturer.
LEVEL 1 NORMOTHERMIC I.V. FLUID ADMINISTRATION SET
Model: D-100, D-60HL, DI-100, DI-50, DI-60HL
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Aluminum leaching
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: D-100, D-60HL, DI-100, DI-50, DI-60HL, H-1000, H-1129, H-1200-EN-115V, H1100, IR-40, IR-500, IR-600
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?
Aluminum leaching
What should consumers do?
Stop using the product immediately. Contact Smiths Medical ASD, Inc. for more 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. Aluminum leaching
When was this product recalled?
This product was recalled on August 27, 2021.
Is the LEVEL 1® brand affected by this recall?
Yes, LEVEL 1® products are affected by this recall. This recall involves LEVEL 1® Fast Flow and Irrigation Fluid Warming Systems sold in Canada. They are being recalled because they may leach aluminum. Stop using the product and follow the return steps in the official notice.