SPIROS CLOSED MALE LUER recall in Canada: Leaking hazard
In plain language
This recall involves certain lots of SPIROS CLOSED MALE LUER medical devices sold in Canada. They are being recalled because they may leak due to a molding defect. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot or model numbers provided.
- Contact ICU Medical Inc. for return instructions.
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Affected products
CLAVE EXT. SET
Model: CH3011, CH3762
Lot: 5125297, 5135759
SPIROS CLOSED MALE LUER
Model: 20120-01
Lot: 5141416
SPINNING SPIROS CLOSED MALE LUER
Model: 20130-01, K7040-001
Lot: 5125300, 5135765, 5142935
Why this matters
Leaking hazard
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: 5125297, 5135759, 5125300, 5135765, 5142935, 5141416
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 20120-01, 20130-01, CH3011, CH3762, K7040-001
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?
Leaking hazard
What should consumers do?
Stop using the product immediately. Check the lot or model numbers provided. Contact ICU Medical Inc. 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. Leaking hazard
When was this product recalled?
This product was recalled on October 1, 2021.
Is the SPIROS brand affected by this recall?
Yes, SPIROS products are affected by this recall. This recall involves certain lots of SPIROS CLOSED MALE LUER medical devices sold in Canada. They are being recalled because they may leak due to a molding defect. Stop using the product and follow the return steps in the official notice.