FDA (Devices) recall action 89327
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.
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
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.
Certain cleaning products can damage Baxter MiniCap PD Transfer Sets, potentially causing them to leak or crack. This could affect the safety of peritoneal dialysis treatment if the damaged set is used.
Baxter CAPD MiniCap Transfer Set II units may leak or crack when cleaned with chemicals including bleach, hydrogen peroxide, or solvents. The recall affects 8,928 units distributed worldwide.
Baxter recalls 62,712 MiniCap Extended Life PD Transfer Sets worldwide due to potential damage from certain cleaning products. Exposure to products containing bleach, hydrogen peroxide, or solvents may cause leaking or cracking.
Baxter Healthcare is recalling 344,190 units of MiniCap Extended Life PD Transfer Sets worldwide because certain cleaning products may cause the sets to leak or crack, potentially affecting patient dialysis treatment.
Baxter is recalling 116,628 peritoneal dialysis transfer sets worldwide because certain cleaning chemicals can damage the device, potentially causing leaking or cracking.
Baxter Healthcare is recalling CAPD MiniCap Transfer Set II units worldwide because certain cleaning products containing chemicals like hydrogen peroxide, bleach, and solvents may cause the sets to leak or crack.
Certain cleaning products can damage Baxter MiniCap Extended Life PD Transfer Sets, causing them to leak or crack. Baxter is recalling approximately 61,290 units sold worldwide.
Baxter Healthcare is recalling approximately 58,194 units of its MiniCap Extended Life PD Transfer Sets distributed worldwide because certain cleaning products may damage the sets, causing leaking or cracking.
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets worldwide because cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents may cause the devices to leak or crack.
Baxter MiniCap Extended Life PD Transfer Sets may be damaged by certain cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents, potentially causing leaking or cracking. No injuries have been reported.
Baxter Healthcare is recalling 2,553,528 units of the MiniCap Extended Life PD Transfer Set worldwide because cleaning products containing certain chemicals may cause the device to leak or crack.