Cardiac Assist recalls 14 kits of Protek Solo Venous Dilator Set with incorrect packaging that could be distributed to patients. Affected units include specific catalog numbers and serial lots.
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.
Cardiac Assist is recalling 14 kits of Protek Solo Venous Dilator Set due to incorrect packaging in finished goods. This could lead to improper use during medical procedures if the kits are used without proper verification.
The recall is for incorrectly packaged dilator sets that were distributed to the field. This could lead to improper use during medical procedures if the kits are used without proper verification. The hazard is not described in detail regarding specific injury risks.
Healthcare professionals using the Protek Solo Venous Dilator Set for percutaneous catheterization are likely affected. Patients receiving the device during medical procedures may be at risk if the incorrect packaging is used.
Check for catalog numbers 5840-2417, 5840-2415, 5740-2417, or 5100-1422 with specific serial lots listed in the UDI codes. The kits were distributed starting in February 2021.
Verify the catalog number and serial lots listed in the UDI codes to confirm if your kit is affected.
Cardiac Assist found that some dilator sets were incorrectly packaged in finished goods, which were distributed to the field starting in February 2021.
14 kits containing the impacted products were distributed to the field.
Check the catalog number and serial lots listed in the UDI codes to confirm if your kit is affected. There is no specific remedy stated in the recall notice.
We’ve drafted a message you can send Cardiac Assist to request your refund or repair — edit it as you like.
Subject: Recall Z-1486-2021 — Cardiac Assist Cardiac Assist Hello, I own a Cardiac Assist that is covered by recall Z-1486-2021 from Cardiac Assist. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
