FDA (Devices) recall action 90032
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.
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
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.
Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.
Baxter Healthcare is recalling locking caps for peritoneal dialysis catheters that were distributed without FDA regulatory clearance. These devices were released into the U.S. market in error.
Baxter Healthcare Corporation is recalling 510 units of 15-liter peritoneal dialysis drain bags that were distributed without required FDA regulatory clearance.
Baxter Healthcare Corporation is recalling 3.65 m peritoneal dialysis extension sets from Lot H19G12025 that were distributed without FDA regulatory clearance. The devices were distributed in error and should not be used.
Baxter Healthcare is recalling 180 APD Drain Manifold units distributed in nine US states because certain product codes lack FDA regulatory clearance. Patients using affected units should contact Baxter Healthcare immediately.
Baxter Healthcare recalled 78 Effluent Sample Bags that were distributed without FDA regulatory clearance. The product was distributed in error across eight states.