Biosense Webster guiding sheath recalled for labeling mismatch
Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.
What this means for you
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: This is a minor labeling error on a medical device where the carton label does not match the inner pouch label. No illnesses or injuries have been reported. The mismatch could affect product identification and traceability in clinical settings.
Plain-English summary
Biosense Webster, Inc. is recalling 316 units of Carto Vizigo Bi-Directional Guiding Sheath (8.5F/Medium, REF D-1385-02-S) due to incorrect labeling. The product name, lot number, and product code on the carton label do not match the label information on the inner sterile pouch.
This labeling discrepancy could affect proper product identification and lot traceability in healthcare settings. The recall involves lot 50000224 (UDI/GTIN: 10846835016277).
The affected products were distributed worldwide, including throughout the United States and Japan. Healthcare providers who received this product should verify that the carton and inner pouch labels match before use and contact Biosense Webster, Inc. with any questions or concerns.
The recalled product
- Product
- Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
- Manufacturer
- Biosense Webster, Inc.
- Category
- Medical Device
- Hazard
- labeling-error
- identification-mismatch
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 (2)
- Lot # 50000224
- UDI (GTIN) : 10846835016277
Distribution
Distributed nationwide across the United States.
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