FDA (Devices) recall action 95524
The FDA (Devices) publishes a recall like this one as 11 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 11 pages.
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
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 is recalling 83,448 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation from the device body.
Baxter Healthcare is recalling 1,496 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation. The affected lots should not be used until assessed by Baxter.
Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set (Part Number T5C4325K) due to increased complaints about the female connector separating from the main body of the device.
Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set due to reports of connector separation that could interrupt dialysis treatment. The recall affects 31,248 units distributed worldwide.
Baxter Healthcare is recalling the MiniCap Extended Life peritoneal dialysis transfer set due to complaints about female connector separation from the main body. The Class II recall affects 3,204 units distributed worldwide.
Baxter is recalling 22,392 units of MiniCap Extended Life PD Transfer Sets (Part Number 5C4482EJ) due to reports of female connector separation. Affected units were distributed worldwide.
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to increasing reports of the female connector separating from the main body. The defect affects 62,718 units distributed worldwide.
Baxter is recalling MiniCap Extended Life PD Transfer Sets (Part Number 5C4482) due to reports of the female connector separating from the main body. Approximately 409,464 units are affected worldwide.
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to reports of the female connector separating from the transfer set body. The defect may compromise dialysis treatment safety.
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to an increase in complaints of female connector separation from the transfer set body. Peritoneal dialysis patients should contact their healthcare provider.
Baxter Healthcare recalls 8,394 MiniCap Extended Life PD Transfer Sets due to complaints of female connector separation from the transfer set body. This mechanical failure could interrupt dialysis treatment.