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.
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal…
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear…
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that…
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that…
Potential presence of particulate matter on the blood side of the dialyzer
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but…
Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or…
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during…
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during…
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during…
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Presence of Particulate Matter: identified as dried skin.
Instructions for use booklet may puncture the outer Tyvek lid.
Instructions for use booklet may puncture the outer Tyvek lid.
Instructions for use booklet may puncture the outer Tyvek lid.
Instructions for use booklet may puncture the outer Tyvek lid.
Instructions for use booklet may puncture the outer Tyvek lid.
Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating…
Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
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.
