Bovie Medical recalls specific ConMed Disposable Bipolar Ablators due to potential pinholes in sterile packaging that could compromise sterility during surgery.
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Bovie Medical is recalling certain ConMed Disposable Bipolar Ablators because the packaging may develop pinholes at the folded edge, risking contamination during surgical procedures. This could lead to infections if the device is used without proper sterility.
The packaging may develop pinholes at the folded edge during manufacturing, which could allow contaminants to enter the sterile device. This poses a risk of infection during surgery if the device is not properly sterilized.
Surgical professionals using the recalled ConMed Disposable Bipolar Ablators for arthroscopic procedures are most at risk. Patients undergoing surgery with these devices could face infection if the packaging is compromised.
Check for catalog numbers C3390A, C3350A, C3350NA, C2455NA, C1860NA, or C3390NA with specific production lots listed in the recall notice. These devices were sold for arthroscopic surgical procedures.
Identify the lot number on the packaging to determine if it is in the recalled list of lots.
The packaging may develop pinholes at the folded edge, which could compromise sterility during surgical procedures.
There is a potential risk of contamination if the packaging is compromised, which could lead to surgical infections.
Check the catalog number and lot number on the packaging against the list of recalled products provided in the recall notice.
We’ve drafted a message you can send Bovie to request your refund or repair — edit it as you like.
Subject: Recall Z-1155-2021 — Bovie Bovie Hello, I own a Bovie that is covered by recall Z-1155-2021 from Bovie. 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.
