Biosense Webster recalls specific Carto Vizigo Bi-Directional Guiding Sheaths due to incorrect labeling on carton versus inner pouch. This mismatch may cause confusion during medical procedures. Affected units include lot #00002137 with UDI 1084683:5016253.
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 product name, lot number, and code on the outer carton label don't match the inner pouch label. This labeling error could lead to confusion during medical procedures, potentially affecting patient safety.
The outer carton label does not match the inner pouch label for the sheath. This mismatch could cause confusion about the product's identity during medical procedures, potentially leading to incorrect usage or delays in treatment.
Healthcare professionals using the specific Carto Vizigo sheaths with lot number 00002137 and UDI 10846835016253 are most at risk. Patients receiving procedures with these sheaths may also be affected.
Check for the lot number 00002137 and UDI (GTIN) 10846835016253 on the carton label. The product is a sterile, 8.5F (Small) Bi-Directional Guiding Sheath with reference code D-1385-01-S and RX CE 2797.
Verify the carton label matches the inner pouch label for product name, lot number, and code.
The product name, lot number, and code on the outer carton label do not match the inner pouch label.
Check if your sheath has lot number 00002137 and UDI 10846835016253. If it does, verify the labels match before use.
The recall record does not mention a remedy or fix for the labeling error.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-1319-2023 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-1319-2023 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.
