Biopsybell recalls EASYNJECT cement infusion device (REF KVTGUN-DS) due to potential unsterilized products. Affected units may pose infection risk if used in vertebroplasty procedures.
Products labeled as sterile were distributed, but may not have been sterilized.
Biopsybell is recalling EASYNJECT devices used in vertebroplasty procedures because some units may not have been properly sterilized. This could lead to infection risks if the device is used in medical procedures.
The recall states that products labeled as sterile may not have been sterilized during manufacturing. This means the device could become contaminated and cause infections if used in medical procedures without proper sterilization.
Medical professionals using EASYNJECT devices for vertebroplasty procedures are most at risk. Patients undergoing these procedures may be affected if the device is not properly sterilized.
Check for the product name 'EASYNJECT' and reference number KVTGUN-DS. The batch number 2003721 is associated with the recalled units.
Look for the reference number KVTGUN-DS and batch number 2003721 on the device.
The recall states that products labeled as sterile may not have been properly sterilized during manufacturing.
The recall record does not specify a remedy, so no action is required beyond checking the device label for the reference number and batch number.
The recall indicates potential unsterilized products, so the device may pose infection risks if used without proper sterilization.
We’ve drafted a message you can send Biopsybell to request your refund or repair — edit it as you like.
Subject: Recall Z-1636-2021 — Biopsybell Biopsybell Hello, I own a Biopsybell that is covered by recall Z-1636-2021 from Biopsybell. 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.
