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FDA Medwatch Alert: Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution

Posted 27 Dec 2013 by Drugs.com

Product Name Product Code NDC Container Size Lot # Exp. 5% Dextrose Injection, USP 2B0089 0338-0017-38 100 mL P285288 Nov-13 0.9% Sodium Chloride Injection, USP 2B1308 0338-0049-31 50 mL P297283 Aug-14 0.9% Sodium Chloride Injection, USP 2B1302 0338-0049-18 100 mL P292326 Apr-14         P293993 May-14 0.9% Sodium Chloride Injection, USP 2B1309 0338-0049-38 100 mL P293514 Apr-14   [Posted 12/27/2013]  ISSUE: Baxter International Inc. initiated a voluntary recall to the hospital/user level of one lot of 5% Dextrose Injection, USP and four lots of 0.9% Sodium Chloride Injection, USP due to particulate matter found in the solutions. Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local ... Read more

Related support groups: Surgery, Extraneal, Lvp Solution, Normosol-R, Inpersol-LM, Dextrose and Ringer's, Dialyte, Ringer's and Dextrose, Inpersol, Delflex, Plasma-Lyte

FDA Medwatch Alert: Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility

Posted 31 Jan 2013 by Drugs.com

ISSUE: Hospira, Inc. is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a spore-like structured particulate, consistent with mold, was noted in the solution. Hospira has not received reports of any adverse events associated with this issue for this lot, and has not identified any quality issues with retention samples for this lot. If contaminated solution is used on a patient, this may cause thrombosis, phlebitis, bacteremia, sepsis, septic shock and/or endocarditis, or result in a fatal infection in a broad array of patients. BACKGROUND: The product is used as a source of water, electrolytes and calories or as an alkalizing agent and is packaged in a 1000 mL flexible container, lot number 05-019-JT, with an ... Read more

Related support groups: Lvp Solution

FDA Medwatch Alert: Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 Ml, Flexible Containers: Recall - Mold Contamination

Posted 8 Oct 2012 by Drugs.com

ISSUE: FDA and Hospira announced it is initiating a voluntary user-level recall of one lot of Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a leak was identified in the primary container between the cobra cap and fill-tube seal and a spore-like structured particulate, consistent with mold, was noted in the solution. When a primary container within an overwrap has a leak, there is an open pathway for contamination of the fluid. The overwrap is not sterile, and any fluid which may have leaked out may become trapped within the overwrap and has the potential to be reintroduced into the primary container. If contaminated solution is used on a patient, critical patient harm may result.  Injections of mold could potentially lead to septicemia (blood stream infections), which in a wo ... Read more

Related support groups: Septicemia, Extraneal, Normosol-R, Lvp Solution, Inpersol-LM, Dextrose and Ringer's, Dialyte, Ringer's and Dextrose, Inpersol, Delflex, Plasma-Lyte

Giving IV Fluids on Scene Might Raise Death Risk for Trauma Victims

Posted 7 Jan 2011 by Drugs.com

THURSDAY, Jan. 6 – The longstanding practice of first giving severely wounded trauma patients intravenous (IV) fluids before bringing them to a trauma center may actually raise their risk of death, a new study suggests. The finding flies in the face of common medical wisdom and mandated protocols in some states that require that IV fluids be given to trauma patients immediately if their blood pressure drops precipitously. But a fresh analysis of data on nearly 777,000 trauma patients revealed that, overall, those who are given pre-hospital IV fluids are actually 11 percent more likely to die than those who aren't, not only because of transport delays but also in part because of the increased risk for bleeding that can accompany a fluid-induced increase in blood pressure. "IV fluid administration to trauma patients pre-hospital is like one of those things that's been thought of as ... Read more

Related support groups: Extraneal, Lvp Solution, Normosol-R, Inpersol, Delflex, Dextrose and Ringer's, Ringer's and Dextrose, Inpersol-LM, Dialyte, Plasma-Lyte

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