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Potential for Medication Overdose with ENFit Low Dose Tip Syringes

October 14th, 2021|

The U.S. Food and Drug Administration (FDA) is informing patients and healthcare providers about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes. The FDA is aware of the potential for overdose if the user does not clear the moat area around the tip of the ENFit

Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing

October 5th, 2021|

Medtronic updated this recall with information that Medtronic will replace any MiniMed™ 600 series insulin pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty

FDA Issues Revised Policy on Face Masks and Respirators During COVID-19

September 20th, 2021|

The U.S. Food and Drug Administration (FDA) issued revised guidance to help expand the availability of face masks, barrier face coverings, and face shields for the general public, including healthcare personnel, and surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for healthcare personnel for the duration of the COVID-19 public health emergency: Enforcement Policy for Face Masks,

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks

September 14th, 2021|

The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines, and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to

Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng

August 26th, 2021|

Letter to Healthcare Providers The U.S. Food and Drug Administration (FDA) is alerting healthcare facility risk managers, procurement staff, and healthcare personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng). The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH)

COVID-19 Vaccine Granted Full FDA Approval

August 23rd, 2021|

The U.S. Food and Drug Administration (FDA) has granted full approval of the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available

FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

August 13th, 2021|

Aug. 12, 2021 | The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered

Sodium Bicarbonate in 5% Dextrose Injection 150 mEq per 1,000 mL by SterRx – Due to Microbial Contamination

August 13th, 2021|

SterRx, LLC announced the voluntary nationwide recall of three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to waterborne microbial contamination. SterRx, LLC has initiated this voluntary recall of Sodium Bicarbonate injection, to the Hospital Pharmacy level. Intravenous administration of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL,

Limar Hand Sanitizer

July 8th, 2021|

Santo Domingo, Dominican Republic – Ardil Comercial is voluntarily recalling one lot of Limar Hand Sanitizer, packaged in 4 oz bottles to the consumer level. The hand sanitizer is being recalled because it is packaged in containers that resemble water bottles. The product poses a risk of ingestion. Ingesting hand sanitizer, which is intended for