Biosense Webster recalls specific Carto Vizigo Bi-Directional Guiding Sheaths due to incorrect labeling on carton vs. inner pouch. Affected units have lot #50000224 and UDI 10846835016277. No immediate action needed as this is a labeling issue, not a safety hazard.
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
Biosense Webster is recalling certain Carto Vizigo Bi-Directional Guiding Sheaths because the carton label doesn't match the inner pouch label. This labeling error doesn't pose a safety risk but could cause confusion during medical procedures.
The carton label does not match the inner pouch label for the sheath. This mismatch could lead to confusion about the product's specifications during medical procedures, but it does not cause physical harm or injury.
Healthcare professionals using the specific model of sheath with lot number 50000224 and UDI 10846835016277 are likely affected. Patients are not at risk as this is a labeling issue, not a safety hazard.
Check for the lot number 50000224 and UDI 10846835016277 on the carton label. The product is a sterile, 8.5F Medium Bi-Directional Guiding Sheath with the specific reference code D-1385-02-S.
Compare the carton label with the inner pouch label to confirm they match the product specifications.
No, this recall is for labeling accuracy, not a safety hazard. The product does not pose a risk of injury or harm.
Check for lot number 50000224 and UDI 10846835016277 on the carton label. The product is a sterile, 8.5F Medium Bi-Directional Guiding Sheath with reference code D-1385-02-S.
No action is required as this is a labeling issue, not a safety hazard. However, verify labels to ensure correct usage.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-1320-2023 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-1320-2023 from Biosense Webster. 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.
