Shelhigh, Inc. implantable medical devices.

Government Resource

Shelhigh, Inc. implantable medical devices.

May 2, 2007

Food and Drug Administration; FDA

This announcement alerts health care providers and consumers to potential contamination of medical devices from one manufacturer.

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FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam).

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Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

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OpenFDA.

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FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved.

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February 29, 2012

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March 6, 2005

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Benzocaine sprays marketed under different names, including Hurricaine, Topex, and Cetacaine.

February 22, 2006

Bar Code Label Requirements for Blood and Blood Components.

April 26, 2006

Interference between CT and Electronic Medical Devices.

July 30, 2008

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November 23, 2005

FDA public health notification: unretrieved device fragments.

January 30, 2008

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.

March 3, 2010

Infections associated with reprocessed flexible bronchoscopes.

September 30, 2015

FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients.

March 11, 2015

Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning.

March 4, 2015

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June 18, 2014

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August 25, 2021

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November 13, 2013

Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.

June 6, 2018

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November 13, 2019

Safety Considerations for Product Design to Minimize Medication Errors: Guidance for Industry.

January 9, 2013

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.

April 17, 2019

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May 4, 2022

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November 16, 2011

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April 8, 2009

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November 19, 2014

Making Medical Devices Safer at Home.

January 9, 2013

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July 31, 2013

Public Health Notification from FDA: Vail Products Enclosed Bed Systems.

December 19, 2007

FDA preliminary public health notification: unpredictable events in medical equipment due to new daylight savings time change.

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Nimodipine Capsules (marketed as Nimotop).

March 1, 2006

Maalox Total Relief and Maalox Liquid Products: Medication Use Errors.

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January 25, 2017

FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.

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FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.

February 7, 2018

FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death.

October 9, 2013

Important change to heparin container labels to clearly state the total drug strength.

December 19, 2012

Kadcyla (ado-trastuzumab emtansine): drug safety communication—potential medication errors resulting from name confusion.

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Hospira Carpuject pre-filled cartridges—drug alert: products may contain more than the intended fill volume.

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July 26, 2006

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March 4, 2015

Relenza (zanamivir) inhalation powder.

October 21, 2009

Potentially fatal errors with GDH-PQQ [glucose dehydrogenase pyrroloquinoline quinone] glucose monitoring technology.

October 21, 2009

Tamiflu (oseltamivir) for oral suspension: potential medication errors.

October 7, 2009

Hydrocodone bitartrate and acetaminophen tablets, phenobarbital tablets by Qualitest: recall—incorrect package labeling.

February 16, 2011

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL): medication use error—reports of accidental overdose.

January 19, 2011

Using ventilator splitters during the COVID-19 pandemic--letter to health care providers.

February 17, 2021

Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death.

February 20, 2013

6 Tips to Avoid Medication Mistakes.

July 18, 2007

Safe Use Initiative.

November 18, 2009

Quick Tips for Buying Medicines Over the Internet.

March 6, 2005

Computerized Prescriber Order Entry Medication Safety (CPOEMS): Uncovering and Learning From Issues and Errors.

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Safety Information on Alaris SE Infusion Pumps.

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Drug Shortages.

April 27, 2011

Reprocessing of Reusable Medical Devices.

January 11, 2012

MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

June 22, 2005

FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration.

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March 8, 2023

Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers.

November 11, 2020

Letter to Health Care Providers: Safe Use of Surgical Staplers and Staples.

October 7, 2021

FDA/ISMP Safe Medication Management Fellowship Program.

February 8, 2023

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September 17, 2008

An Introduction to the Improved FDA Prescription Drug Labeling.

November 1, 2006

Fentanyl transdermal system (marketed as Duragesic) information.

July 10, 2015

Human Factors and Medical Devices.

March 27, 2005

Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff.

October 3, 2022

FDA Funding Available for Research Aimed at Reducing Preventable Harm from Medication

November 6, 2019

FDA Safety Communication: flexible bronchoscopes and updated recommendations for reprocessing.

February 24, 2022 - February 24, 2022

Medication Safety During the COVID-19 Pandemic: What Have We Learned in the United States.

June 23, 2020

My Medicines.

July 9, 2014

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March 29, 2023

Examples of Medical Device Misconnections.

March 8, 2023

The incidence of opioid misuse among the surgical patients with persistent opioid use.

February 8, 2023

Use of recalled devices in new device authorizations under the US Food and Drug Administration's 510(k) pathway and risk of subsequent recalls.

January 25, 2023

Request for Information: Creating a National Healthcare System Action Alliance to Advance Patient Safety.

December 21, 2022

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up.

October 19, 2022

Maternal Health Research Centers of Excellence (U54 Clinical Trial Optional).

August 31, 2022

Use duodenoscopes with innovative designs to enhance safety: FDA Safety Communication.

May 4, 2022

HEAR Her Concerns.

April 6, 2022

COVID-19 Focused Inspection Initiative in Healthcare.

March 23, 2022

Potential for medication overdose with ENFit low dose tip syringe: FDA Safety Communication.

October 20, 2021

Letter to Health Care Providers: Safe Use of Surgical Staplers and Staples.

October 7, 2021

Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11.

September 1, 2021

Use purple bracelets or wristbands only for do not resuscitate status - letter to industry.

August 25, 2021

FDA Safety Communication: update--robotically-assisted surgical devices in mastectomy.

August 20, 2021

Accidental exposures to fentanyl patches continue to be deadly to children.

July 21, 2021

FDA Safety Communication: flexible bronchoscopes and updated recommendations for reprocessing.

February 24, 2022 - February 24, 2022

Hospira issues a voluntary nationwide recall for one lot of 0.5% Bupivacaine Hydrochloride Injection, USP and one lot of 1% Lidocaine HCl Injection, USP due to mislabeling.

May 19, 2021

Hospital Compare.

May 13, 2021

Using ventilator splitters during the COVID-19 pandemic--letter to health care providers.

February 17, 2021

Apotex Corp. issues voluntary nationwide recall of Enoxaparin Sodium Injection, USP due to mislabeling of syringe barrel measurement markings.

February 17, 2021

Meitheal Pharmaceuticals, Inc. issues voluntary nationwide recall of Cisatracurium Besylate Injection, USP 10mg per 5mL due to mislabeling.

February 10, 2021

FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only.

February 3, 2021

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products.

January 13, 2021

Wear face masks with no metal during MRI exams.

December 16, 2020

Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers.

November 11, 2020

FDA advises health care professionals and patients about insulin pen packaging and dispensing.

October 28, 2020

Classification of opioid dependence, abuse, or overdose in opioid-naive patients as a "Never Event".

August 5, 2020

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