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FDA MEDWATCH ALERTS

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January 12, 2012

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

Summary:

FDA notified health care professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm.  Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

January 12, 2012

Bedford Laboratories Vecuronium Bromide And Polymyxin B For Injection USP For Injection: Recall - Glass Particles

Summary:

Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed.

January 09, 2012

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

Summary:

FDA is advising health care professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

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ASA FEATURED PRODUCT

Self-Education and Evaluation (SEE) Program

SKU: 30701-12CE

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Single Copies, Member Price: $300

Anesthesia-Related Businesses

Equipment & Supplies

Agilent

- HP spinoff Agilent's Healthcare Solutions Group became a part of Philips Medical Systems on August 1, 2001.

Arrow International
- Multi-lumen catheters, implantable pumps, etc.

Augustine Medical
- BairHuggers® & other warming devices.

B. Braun Medical
- IV catheters, and a variety of related items. You will need a DocCheck login to access the prescription-only products.

Datex-Ohmeda
- monitors, anesthesia machines. Now a division of GE.

King Systems
- circuits, masks, etc

LMA North America
- all the various LMAs. Requires the Shockwave plug-in.

Mallinckrodt
- parent company of Puritan-Bennett ventilators, Nellcor pulse oximeters, and others.

Medtronic
- pacemakers, AICDs, stents

North American Dräger
- The (English-language) home page of this German maker of anesthesia machines.

Philips Medical Systems
- Monitoring, Info Management, Diagnosis & Resuscitation products, including echocardiography and a variety of telemetry units.

Rüsch
- Laryngoscope systems

SIMS
- Smiths Industries Medical Systems. The makers of Hotlines; & Level1®, also Portex.

Vital Signs
- circuits, masks, etc
 

Information Management Systems

iMDsoft
- iMDsoft's MetaVision Suite of clinical information systems features fully-integrated tools for data collection, presentation, order management, and decision support across ICUs and perioperative environments.

Medications

Abbott Anesthesia
- Anzemet® (dolasetron), Ultane® (sevoflurane), Precedex® (dexmetomidine); IV products & custom kits
Astra-Zeneca
- Diprivan® (propofol), EMLA cream, Naropin® (ropivicaine)
Baxter
- Brevibloc® (esmolol), Suprane® (desflurane); infusion pumps & custom kits
GlaxoSmithKline
- Zofran® (odansetron), Acova® (argatroban) . Glaxo Wellcome and SmithKline Beecham merged in December 2000. The old Glaxo Wellcome site still has some information on it. Unfortunately, the new GSK site is not particularly helpful - you can't search, and all of the meds are not listed.
Merck
- Aggrastat® (tirofiban), Cozaar® (losartan), Vioxx® (rofecoxib). Full prescribing information is available for all of their products; some have separate web pages.
Organon USA
- nondepolarizing muscle relaxants, including Zemuron®, Norcuron®
Purdue-Pharma L.P.
- MS Contin, Oxycontin®


Texts & Journals

Lippincott-Williams & Wilkins
- publishers of Anesthesiology, and other journals.
W.B. Saunders Company
- publishers of Miller's Anesthesia, Kaplan's Cardiac Anesthesia, & Stoelting's Anesthesia & Uncommon Diseases, among others. On-line purchasing. A division of Elsevier Science.