Archive for September 1st, 2010

Recalls and Safety Alerts: Recall of Certain LIFEPAK Defibrillators

Physio-Control has alerted users of LIFEPAK 20 and LIFEPAK 20e defibrillators about possible failures in AC or DC power that could delay or prevent these devices from delivering therapy. If a failure occurs while the device is being used in the AC o…

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Recalls and Safety Alerts: Expanded Recall of Hospira Liposyn and Propofol

Hospira is expanding a recall of several of the company’s injectable products because some of the containers may contain particulate matter, which consists mainly of inert stainless steel particles that are not visible. Because these particulates do …

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Recalls and Safety Alerts: Air/Gas Embolisms with Pressurized Spray Devices

FDA is advising operating room personnel about the importance of using gas or air-pressurized sprayers properly. These products are used to deliver hemostatic agents, including fibrin and non-fibrin sealants.

FDA has reports in which gas and ai…

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Recalls and Safety Alerts: FDA Requirements for Colleague Infusion Pump Recall

Here is information on the steps Baxter Healthcare has to take in order to carry out the recall of its Colleague volumetric infusion pumps. The recall was ordered by FDA earlier this year because of Baxter’s long-term failure to correct serious prob…

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New Medical Products: First Test to Detect Both HIV Antigen and Antibodies

FDA recently approved the first diagnostic test that simultaneously detects HIV antigen and antibodies. The test, called the ARCHITECT HIV Ag/Ab Combo assay, is made by Abbott Laboratories.

Most tests that are presently used in diagnostic setting…

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