Carefusion recalls four endoscope models due to missing instruction manual in packaging. This could lead to improper use if the user doesn't know how to operate the device correctly.
The finished device package did not contain the IFU.
Carefusion is recalling four specific endoscope models because the product packaging did not include the instruction manual. Without the manual, users may not know how to safely operate the device, which could lead to improper use.
The device package does not contain the instruction manual. Without the manual, users may not know how to properly operate the endoscope, which could lead to improper use. However, the hazard is not described as causing serious injury in normal use.
Medical professionals who purchased or use these endoscopes are likely affected. Those who have the specific model numbers listed in the recall are at risk of using the device incorrectly without the necessary instructions.
Check for the specific model numbers and catalog codes listed in the recall. The affected items include CareFusion Snowden-Pencer endoscopes with catalog numbers 88-5910, 88-5920, 88-9808, and 88-9809.
Ensure the product packaging includes the instruction manual. If it does not, contact Carefusion for further instructions.
The recall states that the finished device package did not contain the instruction manual.
Check if your endoscope has the specific catalog numbers listed in the recall. If it does, contact Carefusion for guidance on next steps.
The recall does not state that the missing manual causes serious injury in normal use. The hazard is considered low risk as it does not involve immediate danger.
We’ve drafted a message you can send Carefusion to request your refund or repair — edit it as you like.
Subject: Recall Z-0833-2022 — Carefusion Carefusion Hello, I own a Carefusion that is covered by recall Z-0833-2022 from Carefusion. 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.
