FDA (Devices) recall action 85049

Avid Medical, Inc. recalled 9 products on 2020-03-25

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.

Products: 9
Announced: 2020-03-25
Critical: 0
Units: 34,771

Why these products were recalled

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.

States named across these recalls

1–9 of 9

HighFDA (Devices)··2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
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.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Distribution
13 states
HighFDA (Devices)··2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
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.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Distribution
13 states
HighFDA (Devices)··2020-03-25
Avid Medical Recalls Custom Procedure Trays Containing Non-Sterile Gowns
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.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Distribution
13 states
HighFDA (Devices)··2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
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.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Distribution
13 states
HighFDA (Devices)··2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
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.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Distribution
13 states
HighFDA (Devices)··2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
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.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Distribution
13 states
HighFDA (Devices)··2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
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.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Distribution
13 states
HighFDA (Devices)··2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
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.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Distribution
13 states
HighFDA (Devices)··2020-03-25
Avid Medical Recalls Custom Procedure Trays with Non-Sterile Gowns
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.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Distribution
13 states