Archive for the 'Recall' Category

Dialysis drug recalled after patient death

A Fresenius solution used in hemodialysis machines has been recalled because of concerns over bacteria contamination following a patient death. The U.S. Food and Drug Administration issued a notice this week of the recall, saying it had received one report of death and two reports of injury that may be related to use of Fresenius NaturaLyte Liquid Bicarbonarte Concentrate. Lab testing identified Halmonas, a bacteria typically found in water with high salt concentration, in the product during its shelf life, the FDA said.

Read more about the Fresenius recall…

Fresenius expands NaturaLyte recall in Canada

Fresenius Medical Care has issued a NaturaLyte recall in Canada, citing bacterial contamination as the primary reason for the recall. This recall follows another NaturaLyte and GranuFlo recall in the United States that occurred after the acid concentrates were linked to severe adverse events in dialysis clinics.

Read more about the Naturalyte recall…

Breast Pump Adapters Recalled

Playtex Manufacturing is voluntarily recalling electric breast pump AC/DC power adapters over concerns of potential electric shock, although there have been no known injuries, the FDA announced Thursday.

Read more about the breast pump recall…

Male sexual enhancement drugs recalled

Midwest Wholesale, a Missouri-based company that distributes over-the-counter male sexual enhancement pills, has issued a voluntary recall of several brands because they contain the same effective ingredients found in prescription-only drugs Viagra and Cialis.

Read more about the male enhancement drug recall…

Merck issues voluntary recall of cholesterol drug Liptruzet

Merck said it is recalling its combination cholesterol drug Liptruzet, which was introduced in May, because of packaging defects that could reduce effectiveness. In a statement on its website, Whitehouse Station-based Merck said the recall will clear out the entire stock of Liptruzet, which includes all four dose strengths and every batch it has distributed.

Read more about the Liptruzet recall…

FDA announces Medtronic recall

The U.S. Food and Drug Administration (FDA) has announced a recall of a Medtronic insulin device which could result in diabetes patients getting too much or too little insulin. The Medtronic MiniMed Paradigm Insulin Infusion device could lead to dangerous insulin levels that result in death.

Read more about the Medtronic recall…

Intuitive Surgical May Not Have Tested Devices Properly

Intuitive Surgical Inc. (ISRG), the maker of the da Vinci Surgical System robots, informed customers that 30 devices may not have been tested properly, according to the U.S. Food and Drug Administration. The FDA, calling it a “class 2 recall,” said the action affects Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller, in notices posted on its website yesterday.

Read more about the da Vinci Surgical System recall…

 


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