Recall archive
197 recalls · page 9 of 9
Reported Aug 7, 2013
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
FDA (openFDA drug enforcement)
Reported Jul 3, 2013
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — leaking pouches
10 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2012
5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product details — Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 8, 2012
Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Renal Div
Matched: Brand · Product details · Reason for recall — Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked…
FDA (openFDA device enforcement)
Reported Jun 20, 2012
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 --…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand — Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow…
FDA (openFDA device enforcement)
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