Avid Medical recalls custom procedure trays with non-sterile surgical gowns that could cause surgical site infections. Check item codes and lot numbers for affected units.
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 contain surgical gowns which may not be sterile. This could lead to surgical site infections if used during procedures. The recall affects specific item codes and lot numbers sold between 2020 and 2021.
The surgical gowns in the trays were not properly sterilized due to poor environmental conditions during manufacturing. This could lead to cross-contamination with other tray components and compromise the sterile field during surgery, increasing infection risks.
Healthcare professionals using the recalled trays for patient procedures are most at risk. Patients undergoing surgery with these trays could face infection risks.
Check for item codes SHER010-12 and lot numbers 1339900, 1352089, 1361835, 1370391, or 1372029. These trays were sold between December 2020 and September 2021.
Look for item codes SHER010-12 on the trays.
Check if the lot numbers 1339900, 1352089, 1361835, 1370391, or 1372029 match your product.
The gowns were manufactured at locations that did not maintain proper environmental conditions, so there is no assurance they are sterile.
Inadequately sterilized gowns could compromise the sterile field during surgery, increasing the risk of surgical site infections.
The recall record does not specify a remedy, so contact Avid Medical directly for guidance.
We’ve drafted a message you can send Avid Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1519-2020 — Avid Medical Avid Medical Hello, I own a Avid Medical that is covered by recall Z-1519-2020 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.
