Recall archive
201 recalls · page 9 of 9
Reported Dec 4, 2013
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Incomplete foil seal on one lot of sterile product.
FDA (openFDA device enforcement)
Reported Nov 20, 2013
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Reason for recall — Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2013
Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2013
Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxa Corporation
Matched: Reason for recall — Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.
FDA (openFDA device enforcement)
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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