Baxter Healthcare Corporation: Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

Hazard

The electrical safety testing was not properly performed on the impacted devices and additional testing is required

Details from the source

Reason for recall: The electrical safety testing was not properly performed on the impacted devices and additional testing is required Distribution: US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA. Quantity: 16 units Lot/code info: Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.

UPC codes

0085412676463

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.