FDA (Devices) recall action 75637
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Sterility: Due to a potential incomplete seal on the outer sterile package.
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.
Teleflex Medical is recalling Arrow OnControl Bone Lesion Biopsy System trays due to a potential incomplete seal on the outer sterile package.
Teleflex Medical is recalling Arrow OnControl Bone Marrow Biopsy Systems due to a potential incomplete seal on the outer sterile package.
Teleflex Medical is recalling OnControl Biopsy System Ported Needle Trays due to a potential incomplete seal on the outer sterile package.
Teleflex Medical is recalling 113,647 units of Arrow OnControl Bone Marrow Biopsy System Trays due to a potential incomplete seal on the outer sterile package.
Teleflex Medical is recalling specific lots of Arrow OnControl Ported Aspiration System Trays because the outer sterile package may have an incomplete seal.