FDA (Devices) recall action 65697
The FDA (Devices) publishes a recall like this one as 14 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 14 pages.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
The agency’s own wording, quoted from the enforcement report.
Atrium Medical Corporation is recalling Flixene IFG with Assisted Delivery because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Flixene Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Advanta SuperSoft Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Advanta VXT Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Advanta SST Bifurcated Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Advanta SuperSoft Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Advanta VS Grafts because the inner tray label may adhere to the outer tray, making removal difficult.
Atrium Medical Corporation is recalling Flixene IFG Vascular Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Flixene Trumpet Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making removal difficult.
Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Advanta VS Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Atrium Medical Corporation is recalling Advanta VXT Vascular Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.