Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Summary
The FDA issued a Class II for Automated Peritoneal Dialysis System. Used for automatic control of dialysis so by Baxter Healthcare Corporation. Reason: The electrical safety testing was not properly performed on the impacted devices and additional testing is required.
Details
Source
Device Recall
External ID
Z-1316-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
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.
Quantity Affected: 16 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-22
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1316-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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