Genicon recalls disposable specimen retrieval bags that may be used for multiple specimens, risking contamination. Affected units include model 550-000-00:000 with lot I8920 from August 2020.
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Genicon is recalling disposable specimen retrieval bags that can be used for multiple specimens instead of being single-use. This could lead to contamination or infection risks if the bag isn't properly sterilized between uses.
The bags are designed for single use only but may be used multiple times. Reusing the bag without proper sterilization could lead to contamination or infection risks.
Healthcare workers and lab personnel who use these bags for specimen collection are most at risk. The recall affects units purchased from August 2020 with specific model and lot numbers.
Check for model number 550-000-000 and lot number I8920 from August 2020. The bags are labeled as disposable and sterilized for single use only.
Look for model number 550-000-000 and lot number I8920 from August 2020 on the bag.
The bags are designed for single use only but may be used for multiple specimens, risking contamination.
Check for model number 550-000-000 and lot number I8920 from August 2020 on the bag.
The recall does not require immediate action; check the label to confirm if you have the affected model and lot number.
We’ve drafted a message you can send Genicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2005-2020 — Genicon Genicon Hello, I own a Genicon that is covered by recall Z-2005-2020 from Genicon. 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.
