FDA (Devices) recall action 76620
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
The integrity of the sterile packaging is potentially compromised.
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.
Carefusion 2200 Inc is recalling 14,200 Jamshidi (TJ) needles because the integrity of the sterile packaging is potentially compromised.
Carefusion 2200 Inc is recalling specific lots of Illinois needle aspiration devices because their sterile packaging integrity is potentially compromised.
Carefusion 2200 Inc is recalling 790 units of Jamshidi Needle Biopsy devices because the integrity of the sterile packaging is potentially compromised.
Carefusion 2200 Inc is recalling 1,200 sterile thoracentesis and paracentesis kits because their packaging integrity may be compromised.
Carefusion 2200 Inc is recalling sterile Jamshidi bone marrow needles because the integrity of the sterile packaging is potentially compromised.
Carefusion 2200 Inc is recalling 4,240 units of sterile manometers because the integrity of the sterile packaging is potentially compromised.