Reported Apr 5, 2023 · Ongoing
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 5C6M40— — 0085412676463UDI/DI: 0085412676463 — Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603. - Amount recalled
- 16 units
Where it was sold
Why it was recalled
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
This product could cause temporary or reversible health problems — stop using it.
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