FDA (Devices) recall action 85049
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Avid Medical, Inc. is recalling 1,644 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Avid Medical is recalling 21,326 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Avid Medical, Inc. is recalling 628 custom procedure trays because they contain surgical gowns that may not be sterile. This poses a risk of surgical site infection and cross-contamination.
Avid Medical is recalling 5,004 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Avid Medical is recalling 400 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Avid Medical, Inc. is recalling 1,906 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Avid Medical is recalling 2,632 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Avid Medical, Inc. is recalling 1,001 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Avid Medical is recalling 230 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.