FDAFDA · Food and drugs·Recall number Z-1316-2023
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Published April 5, 2023 · Recall initiated: February 22, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
- Lot
- Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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