Overview of recall records associated with Baxter Healthcare Corp., including dates, categories and classifications where available.
Classification mix: Class II: 93, Class I: 28, Class III: 3.
Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with…
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function,…
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function,…
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function,…
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function,…
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port…
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Potential for device malfunction resulting in flow when the device should not be flowing
Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest…
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Lack of Assurance of Sterility; increased complaints received for leaks
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or…
Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates,…
Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.
This page summarizes recall records in which the official source identifies Baxter Healthcare Corp. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
