M.D.L. recalls specific Mammary Nodules Localization models due to potential sterility issues. Affected units include PN2010, PN2012, PN2015, PNA2005, and others with listed lots. No remedy provided in official notice.
Sterility assurance may be compromised.
M.D.L. is recalling certain Mammary Nodules Localization devices because they might not maintain sterility properly. This could lead to infections if used in medical procedures. The recall affects specific model numbers and production lots.
The device may not maintain sterility during use, which could lead to infections if it comes into contact with the body. This is a critical concern in medical settings where sterility is essential to prevent complications.
Medical professionals using the Mammary Nodules Localization devices are likely affected. Patients undergoing procedures with these devices may be at risk if the sterility issue is not addressed.
Check for model numbers PN2010, PN2012, PN2015, PNA2005, PNX2010, PNS2010, PR2005, PR2007, and PR2010 with the listed production lots. The device is sold under the brand M.D.L.
Identify the model number and production lot from the device label to determine if it is affected.
The official recall notice does not provide a remedy for this issue.
Affected models include PN2010, PN2012, PN2015, PNA2005, PNX2010, PNS2010, PR2005, PR2007, and PR2010 with specific production lots listed in the recall notice.
Check the model number and production lot on your device label against the list provided in the recall notice.
We’ve drafted a message you can send M.D.L. to request your refund or repair — edit it as you like.
Subject: Recall Z-2491-2021 — M.D.L. M.D.L. Hello, I own a M.D.L. that is covered by recall Z-2491-2021 from M.D.L.. 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.
