Arrow-Trerotola Products recall in Canada: tip separation risk
In plain language
This recall involves Arrow-Trerotola Percutaneous Thrombolytic Devices sold in Canada. They are being recalled because the device tip may separate during use. Stop using the product and contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Check the model and lot numbers provided in the recall notice.
- Contact the manufacturer for additional information.
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Affected products
Arrow-Trerotola Percutaneous Thrombolytic Device Rotator Drive Unit
Model: PT-65509-HFC
Lot: 13F20D0386, 13F20M0183, 13F21G1344, 13F20G0176, 13F20A0359, 13F20B0140, 13F20J0139, 13F21H0213, 13F21B0224, 13F21C0366, 13F20F0576, 13F20J0547, 13F21E0078, 13F20C0593
Arrow-Trerotola Percutaneous Thrombolytic Device Kit
Model: PT-45509, PT-65509
Lot: 13F20J0545, 13F21G0226, 13F20D0127, 13F20A0209, 13F21C0365, 13F20C0427, 13F20D0402, 13F20G0285
Arrow-Trerotola Over-The-Wire Ptd Kit
Model: PT-12709-WC, PT-65709-HFWC, PT-65709-W, PT-65709-WC
Lot: 13F20G0284, 13F20B0053, 13F20C0094, 13F20G0361, 13F21C0748, 13F20G0566, 13F21C0080, 13F20F0577, 13F21A0354, 13F20H0756, 13F20F0578, 13F20F0230, 13F21A0353, 13F21E0415, 13F20L0282, 13F20A0323, 13F20M0182, 13F20L0514, 13F20C0596, 13F21C0747, 13F20B0139, 13F20K0849, 13F20L0283
Why this matters
Tip separation during use
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: 13F20D0386, 13F20M0183, 13F21G1344, 13F20G0176, 13F20A0359, 13F20B0140, 13F20J0139, 13F21H0213, 13F21B0224, 13F21C0366, 13F20F0576, 13F20J0547, 13F21E0078, 13F20C0593, 13F20G0284, 13F20B0053, 13F20C0094, 13F20G0361, 13F21C0748, 13F20G0566, 13F21C0080, 13F20F0577, 13F21A0354, 13F20H0756, 13F20F0578, 13F20F0230, 13F21A0353, 13F21E0415, 13F20L0282, 13F20A0323, 13F20M0182, 13F20L0514, 13F20C0596, 13F21C0747, 13F20B0139, 13F20K0849, 13F20L0283, 13F20J0545, 13F21G0226, 13F20D0127, 13F20A0209, 13F21C0365, 13F20C0427, 13F20D0402, 13F20G0285
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: PT-12709-WC, PT-45509, PT-65509, PT-65509-HFC, PT-65709-HFWC, PT-65709-W, PT-65709-WC
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?
Tip separation during use
What should consumers do?
Stop using the product immediately. Check the model and lot numbers provided in the recall notice. Contact the manufacturer 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. Tip separation during use
When was this product recalled?
This product was recalled on January 18, 2022.
Is the Arrow International Llc brand affected by this recall?
Yes, Arrow International Llc products are affected by this recall. This recall involves Arrow-Trerotola Percutaneous Thrombolytic Devices sold in Canada. They are being recalled because the device tip may separate during use. Stop using the product and contact the manufacturer for more information.