Medical device recall in Canada: IABP batteries may cause power loss
In plain language
This recall involves CS300, CS100, Cardiosave Hybrid, and Cardiosave Rescue IABP medical devices in Canada. They are being recalled because improper battery maintenance could lead to less than expected operating power. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers: 0998-00-3023-XX, 0998-00-0446H53, 0998-00-0479H62, 0998-00-0800-XX.
- Follow the operating instructions manual for battery usage, charging, maintenance, and storage.
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Affected products
CS300 IABP
Model: 0998-00-3023-XX
Lot: All lots
CS100 IABP
Model: 0998-00-0446H53, 0998-00-0479H62
Lot: All lots
Cardiosave Hybrid IABP and Cardiosave Rescue IABP
Model: 0998-00-0800-XX
Lot: All lots
Why this matters
Loss of operating power
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 0998-00-0446H53, 0998-00-0479H62, 0998-00-0800-XX, 0998-00-3023-XX
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?
Loss of operating power
What should consumers do?
Stop using the product immediately. Check model numbers: 0998-00-3023-XX, 0998-00-0446H53, 0998-00-0479H62, 0998-00-0800-XX. Follow the operating instructions manual for battery usage, charging, maintenance, and storage.
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. Loss of operating power
When was this product recalled?
This product was recalled on July 9, 2019.