Class II · TerminatedJul 18, 2019
Baxter Healthcare Corporation — Lack of Assurance of Sterility: Bags have potential to leak.
Class II · TerminatedSep 6, 2018
Baxter Healthcare Corporation — cGMP Deviation
Class II · TerminatedAug 21, 2018
Baxter Healthcare Corporation — CGMP Deviations
Class II · TerminatedJul 6, 2017
Baxter Healthcare Corporation — Lack of Assurance of Sterility: Customer complaints for leaking bags.
Class II · TerminatedJul 6, 2017
Baxter Healthcare Corporation — Lack of Assurance of Sterility: Bags have the potential to leak.
Class I · TerminatedDec 15, 2015
Baxter Healthcare Corp. — Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class II · TerminatedSep 2, 2015
Baxter Healthcare Corporation — Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Class I · TerminatedJul 17, 2015
Baxter Healthcare Corp. — Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class II · TerminatedJul 2, 2015
Baxter Healthcare Corp. — 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 protectors.
Class I · TerminatedMar 24, 2015
Baxter Healthcare Corp. — Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class II · TerminatedMar 23, 2015
Baxter Healthcare Corp — Lack of Assurance of Sterility; increased complaints received for leaks
Class II · TerminatedMar 18, 2015
Baxter Healthcare Corp. — Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Class II · TerminatedJul 30, 2014
Baxter Healthcare Corp. — Lack of Assurance of Sterility; complaints of mold in the overpouch
Class I · TerminatedJul 11, 2014
Baxter Healthcare Corp. — Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · TerminatedNov 21, 2013
Baxter Healthcare Corp. — Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Class II · TerminatedMay 21, 2013
Baxter Healthcare Corp. — Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.