Buy this domain.

Sierra Pre-Filled Heparin Syringes Recalled After FDA Inspection Finds Problems with Company’s Quality System | cialis online

Sierra Pre-Filled Heparin Syringes Recalled After FDA Inspection Finds Problems with Company’s Quality System

AddThis Social Bookmark Button

Sierra Pre-Filled Heparin Syringes have been recalled by the Food & Drug Administration (FDA) after it was discovered that the medical devices were contaminated with dangerous bacteria.  The Centers for Disease Control and Prevention (CDC) is also investigating dozens of blood infections linked to the Sierra Pre-Filled Syringes contaminated with bacteria.  In announcing the Sierra Pre-Filled Syringe recall, the FDA said that an ongoing inspection of Sierra Pre-Filled showed that the firm is “not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes”.

Around 40 people have been sickened in Texas and Illinois by the tainted Sierra Pre-Filled Syringes, including 20 outpatients at Rush University Medical Center in Chicago; no deaths have been reported.  Of the 20 Rush outpatients who fell ill, 14 required hospitalization.  Although all responded quickly to antibiotic treatment, one patient remains hospitalized as of Tuesday, said Dr. John Segreti, hospital epidemiologist.

Doctors at Rush were able to trace the infections to heparin-filled Sierra Pre-Filled Syringes the patients used during home treatment for cancer and other ailments.  Heparin is a blood thinner and the syringes are used to clear out catheters and intravenous lines.  The infections were caused by bacteria found in a single batch of the heparin-filled syringes made in North Carolina, by a company called Sierra Pre-Filled.  The infections were caused by a bacterium called Serratia marcescens (pronounced Sur-AY’-she-uh mar-SUH’-sens).  Syringes from that batch were also sent to Colorado, Florida, and Pennsylvania but infections—so far—have turned up only in Illinois and Texas, said Dr. Arjun Srinivasan of the CDC.  The infections can cause fever and chills and can be serious but generally respond well to antibiotics.

The Sierra Pre-Filled Syringe recall includes the company’s Heparin Lock Flush Solution USP, 100 units/ml, 5ml in pre-filled syringes; lot number: 070926H; NDC number: 64054-1003-02; Catalog number: 1003-02.  The CDC is working to ensure doctors are alerted about the contamination; doctors and hospitals should be aware that more cases could surface.  The FDA is asking doctors are advised to trace the recalled Sierra Pre-Filled Syringes and make sure their patients stop using them at once. The contaminated Sierra Pre-Filled Syringes should be put into “quarantine” and returned to the distributor.

Heparin is the same drug linked to recent overdoses accidentally given to actor Dennis Quaid’s newborn twins.  In that case, the heparin was made by Deerfield, Illinois-based Baxter Healthcare Corporation.  The overdoses given to the Quaid twins were a result of the babies being dosed with medication from the 10,000 unit vials used for adults and not the 10 unit vials for babies.  Also this year, an alert was issued after three infants died in Indiana after they were mistakenly given adult doses of heparin.  Six other newborns received an overdose and were not among the first to be affected in this sort of mix-up, apparently also happening back in 2001 when two patients were given incorrect dosages of the drug.  Both the 10,000 unit adult vials and the 10 unit baby vials of heparin bear similar packaging which seems to be at the root of under and overdosing errors.

« »

Leave a Reply

You must be logged in to post a comment.




Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!

Whistle Blower

Stand up and say what you think is right. See something, say something.