Medline recalls breast biopsy kits with perforated sterile packaging that may not keep contents sterile. Affected kits have reorder number DYNDA1224B. Stop using if you own this kit.
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Medline is recalling breast biopsy kits because the packaging has a perforation that prevents the outside from staying sterile. This means only the contents inside the kit's wrapping are sterile, which could lead to infection if used improperly.
The kit's packaging has a perforation that allows the outside of the wrapping to become non-sterile. This means the contents inside the kit's wrapping may not stay sterile during use, increasing infection risk.
Healthcare professionals and patients who use Medline breast biopsy kits with reorder number DYNDA1224B are affected. Those performing procedures with these kits are at higher risk due to potential infection.
Check for the kit labeled 'MEDLINE BREAST BIOPSY KIT' with reorder number DYNDA1224B. The kit also has GTIN 40193489468510 and lot number 22HMD545.
Look for the kit label with reorder number DYNDA1224B and GTIN 40193489468510.
The recall is due to a perforation in the packaging that prevents the outside from staying sterile, meaning only the contents inside the wrapping are sterile.
Check for the kit labeled 'MEDLINE BREAST BIOPSY KIT' with reorder number DYNDA1224B, GTIN 40193489468510, and lot number 22HMD545.
The recall record does not specify a remedy, so contact Medline directly for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1114-2023 — Medline Medline Hello, I own a Medline that is covered by recall Z-1114-2023 from Medline. 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.
