Avid Medical recalls custom procedure trays that may contain non-sterile surgical gowns, increasing infection risk during surgery. Affected items include specific lot numbers and expiration dates.
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
Avid Medical is recalling custom procedure trays that may contain surgical gowns not properly sterilized. These gowns could lead to infections during surgery if used without proper sterility.
The surgical gowns in the trays were not sterilized properly due to inadequate environmental controls. This could lead to contamination of the surgical site and increase infection risks during procedures.
Healthcare professionals using the recalled trays for surgeries are most at risk. Patients undergoing procedures with these trays could face infection risks.
Check for item codes ADVC065-18, ADVC068-21, ADVH078-17, or ADVM042-07. Look for lot numbers listed in the expiration dates range from 05/01/2020 to 09/30/2021.
Identify if your trays have item codes ADVC065-18, ADVC068-21, ADVH078-17, or ADVM042-07.
Confirm if your trays have lot numbers from 1324410 to 1381272 as listed in the recall notice.
The gowns were not sterilized properly due to inadequate environmental conditions, which could lead to surgical site infections.
Check for item codes ADVC065-18, ADVC068-21, ADVH078-17, or ADVM042-07 and lot numbers from 1324410 to 1381272.
The recall does not require immediate stop use; however, affected items should be checked for proper sterility before use.
We’ve drafted a message you can send Avid Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1518-2020 — Avid Medical Avid Medical Hello, I own a Avid Medical that is covered by recall Z-1518-2020 from Avid Medical. 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.