Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Protek Solo Venous Dilator Set: dilator Recalled by Cardiac Assist, Inc Due to On 02/26/2021, it was found that there were...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cardiac Assist, Inc directly.
Affected Products
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)
Quantity: 13 kits
Why Was This Recalled?
On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cardiac Assist, Inc
Cardiac Assist, Inc has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report