Cordis recalls Avanti+ Catheter Sheath Introducer due to being larger than labeled dimensions, which may cause improper use in medical procedures.
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Cordis is recalling Avanti+ Catheter Sheath Introducers because the product is larger than what the labeling shows. This could lead to improper use during medical procedures if the sheath is too big for the intended application.
The sheath is physically larger than the labeling indicates. This could cause improper use during medical procedures if the sheath is too large for the intended application, potentially leading to complications.
Healthcare professionals who use this catheter sheath for arterial or venous procedures are likely affected. The risk is low as the hazard relates to labeling discrepancies rather than immediate safety issues.
Check for the product name 'Avanti+ Catheter Sheath Introducer' with catalog numbers 504-657A. Lot numbers 17919780 (expiring 12/31/2022) and 17988227 (expiring 10/31/2023) are also indicators.
Look for the catalog number 504-657A and lot numbers 17919780 or 17988227 on the packaging.
The product is larger than what the labeling indicates, which could lead to improper use during medical procedures.
The recall record does not specify a remedy, so no action is required beyond checking the product label.
The recall indicates a labeling discrepancy, not a risk of serious injury, so the danger level is low risk.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-2079-2021 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-2079-2021 from Cordis. 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.
