Cardinal Health recalls Argyle UVC Insertion Tray with Safety Scalpel N11 due to risk of delayed treatment causing death in neonatal care. All units sold are affected.
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
Cardinal Health is recalling Argyle UVC Insertion Trays with Safety Scalpel N11 because the device may not unlock properly after use, potentially delaying critical neonatal treatment and risking death. This recall affects all units sold.
The Safety Scalpel N11 has a permanent locking feature that prevents clinicians from unlocking it once the safety shield is closed. This can cause treatment delays during critical neonatal procedures, which may lead to death.
Healthcare providers using the Argyle UVC Insertion Tray with Safety Scalpel N11 for neonatal umbilical catheter procedures are affected. Newborns receiving this treatment are at highest risk.
Check for the Argyle UVC Insertion Tray with Safety Scalpel N11 (vendor part number 73-1811). All units sold are affected, including those with product code 43201.
Immediately stop using the Argyle UVC Insertion Tray with Safety Scalpel N11 as it poses a risk of delayed treatment that could cause death.
The Safety Scalpel N11 has a permanent locking feature that prevents clinicians from unlocking it once the safety shield is closed, which can delay critical neonatal treatment and potentially cause death.
Product code 43201; all lot codes are affected.
The recall record does not mention any remedy or fix.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-2244-2021 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-2244-2021 from Cardinal Health. 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.
