Nucryo Vascular recalls specific PolarCath Balloon Catheter lots due to mislabeled sterilization. E-Beam sterilized units labeled as EO sterilized may pose risks. Affected lots include CAT 0738-0758.
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
Nucryo Vascular is recalling certain lots of PolarCath Balloon Catheters because they were mislabeled as EO sterilized when they were actually E-Beam sterilized. This mislabeling could lead to improper use if the catheter is handled incorrectly, though the recall does not specify a direct safety risk.
The catheters were mislabeled as EO sterilized when they were actually E-Beam sterilized. This could cause confusion about the sterilization process, potentially leading to improper handling or use if healthcare workers assume different sterilization requirements.
Healthcare professionals using the PolarCath Balloon Catheter for vascular procedures are most likely affected. Patients using these catheters during procedures may be at risk if the mislabeling leads to incorrect sterilization handling.
Check the lot numbers on the catheter packaging: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758. The catheter is a coaxial design with two concentric balloon systems.
Verify the lot number on the catheter packaging to see if it matches the affected lots listed: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758.
The catheters were mislabeled as EO sterilized when they were actually E-Beam sterilized, which could lead to confusion about sterilization requirements.
Check the lot number on the catheter packaging. If it matches the affected lots, contact Nucryo Vascular for further instructions.
The recall does not specify a direct safety risk, but mislabeling could cause confusion about sterilization procedures.
We’ve drafted a message you can send Nucryo Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0507-2020 — Nucryo Vascular Nucryo Vascular Hello, I own a Nucryo Vascular that is covered by recall Z-0507-2020 from Nucryo Vascular. 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.
