Nucryo PolarCath Balloon Catheters Recalled for Incorrect Sterilization Labeling
Nucryo Vascular Inc. is recalling 49 PolarCath Balloon Catheters because they were mislabeled as ethylene oxide sterilized instead of E-beam sterilized.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states no illnesses or injuries were reported. The hazard is a labeling error regarding sterilization method, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk issues without reported harm.
Plain-English summary
Nucryo Vascular Inc. is recalling 49 units of the PolarCath Balloon Catheter. The recall involves specific lots (CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, and CAT 0758) distributed in California, Texas, Oklahoma, Arkansas, Michigan, and Mississippi. No foreign distribution occurred.
The recall was initiated because the peripheral dilation catheters, which were E-beam sterilized, were inadvertently mislabeled with ethylene oxide (EO) sterilized labels. This labeling error could lead to confusion regarding the sterilization method used for the medical devices.
Healthcare providers and facilities that have received these specific lots should stop using the affected catheters and contact the manufacturer for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths.…
- Manufacturer
- Nucryo Vascular Inc.
- Hazard
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lots: CAT 0738
- CAT 0739
- CAT 0740
- CAT 0743
- CAT 0744
- CAT 0746
- CAT 0750
- CAT 0751
- CAT 0758
Distribution
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