Yourlawyer.com (Sierra Pre-Filled Syringe News) http://www.yourlawyer.com/topics/overview/Syringes_Linked_to_Bacterial_Infections Sat, 21 Nov 2009 17:19:54 -0800 pixel-app en FDA Failed to Protect Public from Deadly Tainted Syringes http://www.yourlawyer.com/articles/read/16622 Mon, 08 Jun 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16622 tainted pre-filled syringes from the AM2PAT facility in North Carolina from endangering patients, according to a new investigation by The Chicago Tribune and ProPublica.   The bacteria-laden AM2PAT prefilled syringes were linked to serious and sometimes deadly illnesses in 2007 before they were finally recalled.

The Tribune/ProPublica investigation found several instances where the Food & Drug Administration (FDA) failed to follow-up on possible problems at AM2PAT. In March 2005, a pharmacist reported large amounts of orange sediment  floating in an AM2PAT syringe, as well as an inch-long black hair suspended in another.  An inspector visited the facility in June, the report said, and noted nine "significant violations", and AM2PAT was issued an FDA warning letter.  But following a January 2006 inspection, the FDA determined that AM2PAT had fixed the problems cited the previous June.

According to Tribune/ProPublica  article, in 2007 the FDA received another complaint about "white, wispy material" in syringes made at AMPAT2.  Another report from the same time period cited brown particles in another syringe from the same batch. An AM2PAT worker also claimed management  was not adhering to the appropriate clean room temperature during manufacturing, the article said.

The FDA launched another inspection that  June, but when agency personnel arrived, they found the AM2PAT facility shut down.  According to the Tribune/ProPublica investigation, AM2PAT had moved to another facility 30 miles away without ever letting the FDA know.  

In August 2007, an FDA inspector finally arrived at the new AM2PAT facility to investigate the reports of particulate matter in some of the syringes shipped from the factory.  According to the Tribune, the inspector reported back that the plant had a plan to deal with rust, but did not report that it had switched to an unreliable sterilization method.

What the inspector did not known was that on July 30, AM2PAT's customer, B. Braun Medical had recalled over a million syringes because of particulate matter. The FDA's Philadelphia office, which would issue a press release about the recall six weeks after it actually occurred, never informed the agency's Atlanta office, which was conducting the inspection of AM2PAT.   According to the Tribune/ProPublica investigation, the FDA's release about the B. Braun recall noted that particles in the syringes  were medical-grade silicone, and were capable of causing brain damage or a deadly clot.

 According to the Tribune/ProPublica report, the July 30 recall  should have prompted the FDA to conduct a more thorough inspection of the AM2PAT facility, but it never did.  A spokesperson for the agency told the Chicago Tribune that the agency is so understaffed that it no longer follows its own policy except in cases where a recalled device poses a reasonable probability of serious injuries or deaths.

 By December 2007, the FDA was receiving  reports of infections linked to AM2PAT  syringes.  In December 2007 and January 2008, Sierra Pre-filled and B. Braun syringes were recalled by AM2PAT because of the contamination issues. It turns out that the pre-filled syringes were tainted with a bacteria called Serratia marcascens, which in healthy people may cause fever and chills, and generally responds well to antibiotics.  But many of those using the tainted AM2PAT syringes were undergoing chemotherapy treatments, or suffered other health problems which would have compromised their immune system.  In those patients, exposure to the bacteria could prove deadly.  

The infections finally prompted the FDA to  order  a comprehensive inspection of the AM2PAT facility.   According to The Chicago Tribune, inspectors uncovered a variety of problems, including a "gummy brown " substance on the syringe-filling machine and brown water flowing from taps. The FDA also determined that AM2PAT kept two sets of records to cover up its poor sterility testing practices.  As a result of these findings, the AM2PAT plant was finally closed in January 2008. But by that time, the damage had been done.  At least 162  people were sickened by the tainted syringes, and at least  four  died from their illnesses.  

As we reported in February, AM2PAT  plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma - were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace.  Both had pled guilty and had agreed to provide information about plant owner Dushyant Patel.  Patel was  indicted on 10 charges that include fraud and selling adulterated medical devices.  Patel  is currently a fugitive, but if convicted on all charges, could face as much as 95 years in prison.

]]> Tainted Syringe Maker Had History of Violations http://www.yourlawyer.com/articles/read/16139 Thu, 26 Feb 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/16139 tainted pre-filled syringes linked to five deaths received a warning letter in August 2005 from the Food & Drug Administration (FDA) regarding atrocious conditions at its Raleigh, North Carolina manufacturing facility.  According to an Associated Press report, that FDA warning letter discussed nine serious violations found at the AM2PAT plant in Raleigh.  

Federal prosecutors have charged that AM2PAT knowingly shipped untested syringes that sickened hundreds and killed five people.  Many of those using the syringes were undergoing chemotherapy treatments which would have compromised their immune systems. In December 2007 and January 2008, Sierra Pre-filled and B. Braun syringes were recalled by AM2PAT because of the contamination issues.

The company's Angier, North Carolina facility was shut down because the problems.  As we reported yesterday, the plant's manager and quality control director  were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace.  Both had pled guilty and had agreed to provide information about plant owner Dushyant Patel.  Patel, who may have fled to his home in India, was indicted last week on 10 charges that include fraud and selling adulterated medical device. Interpol is reportedly assisting in the international search for Patel.

According to the Associated Press, the problems cited by the 2005 FDA warning letter included poor documentation of sterility tests; insufficient efforts to maintain a sterile environment; and unqualified workers at its facility in Raleigh, North Carolina.  AM2PAT promised to fix those problems, and the FDA was apparently satisfied that it had done so when it inspected the facility again in 2006. Sometime after that, AM2PAT moved production from Raleigh to Angier, North Carolina, some 20 miles away.

According to the Associated Press, the FDA inspected the Angier plant in August 2007, and said it only found a problem with labeling.  But that was the same month it started receiving complaints that debris had been found in "muddy brown" AM2PAT syringes.  Despite these reports, the FDA did not go back to the plant until the Centers for Disease Control traced infections to the tainted AM2PAT syringes.

]]> Company Knowingly Shipped Tainted Syringes That Killed Five http://www.yourlawyer.com/articles/read/16131 Wed, 25 Feb 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/16131
As we reported previously, in 2007  numerous infections from Serratia marcascens bacteria were traced to heparin-filled syringes made by AM2PAT. In December 2007 and January 2008, Sierra Pre-filled and B. Braun syringes were recalled by AM2PAT because of the contamination issues.

The AM2PAT facility  in North Carolina was shut down after the contamination problems were discovered.  At the time, the Food & Drug Administration (FDA) said that inspections of the facility revealed that the company is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

According to the Associated Press, the tainted syringes  were eventually linked to hundreds of infections, some of which resulted in spinal meningitis and permanent brain damage.. Many of those using the tainted Sierra Pre-Filled syringes were undergoing chemotherapy treatments which would have compromised their immune systems.

According to a report in Newsday, AM2PAT  plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma - were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace.  Both had pled guilty and had agreed to provide information about plant owner Dushyant Patel.  Patel, who may have fled to his home in India, was indicated last week on 10 charges that include fraud and selling adulterated medical devices, Newsday said.

According to the Associated Press, prosecutors charge that AM2PAT allowed syringes to ship before they were checked for signs of contamination. Reports detailing the testing were backdated to appear they passed procedure before shipping, and some test results were manipulated or fabricated in an attempt to deceive inspectors from the FDA.

According to prosecutors, the company sold nearly $7 million worth of heparin and saline syringes in 2006-07.  If found and convicted of all charges, Patel could face as much as 85 years in prison, the Associated Press said.

]]> Sierra Pre-Filled Syringe Debacle Yields Five More Lawsuits http://www.yourlawyer.com/articles/read/13759 Fri, 25 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13759 Sierra Pre-Filled syringe lawsuit plaintiffs allege they became seriously ill and were hospitalized because of the defective medical devices.

In December, doctors traced numerous infections to heparin-filled syringes used during home treatment for cancer and other ailments. Around 40 people were sickened, including 20 outpatients at Rush.  Of the 20 who fell ill, 14 required hospitalization.  Doctors at Rush were able to trace the infections to heparin-filled syringes patients used during home treatment for cancer and other ailments.  The Sierra Pre-Filled syringes were found to be contaminated with Serratia marcescens bacteria.  

Dushyant Patel, president of Angier, N.C.-based Sierra Pre-Filled, told The Associated Press on Thursday that he did not know about the new lawsuits and couldn't comment.

Another woman, Katie Abrams, a 30-year-old leukemia patient, filed in December what is believed to be the first lawsuit involving the tainted syringes.  More lawsuits are expected.  Abrams claimed a batch of Sierra Pre-Filled heparin syringes contaminated with bacteria made her fall violently ill.  Abrams was hospitalized for nine days after using the Sierra Pre-Filled Syringes at home, when she "became ill with uncontrollable shaking, vomiting and a fever that reached as high as 105.5 degrees Fahrenheit."

In December 2007, Sierra Pre-Filled recalled syringes from the lot that was implicated in the infections.  Then, on January 18th, the Food and Drug Administration (FDA) and Sierra Pre-Filled announced an expansion of the recall to include all lots and sizes of the heparin and saline pre-filled syringes because they were tainted with the bacteria Serratia marcescens.

The Sierra Pre-Filled syringe products are distributed under two brand names:  Sierra Pre-Filled Inc. and B. Braun and products are sold in pre-filled syringes in 3 ml and 5 ml sizes for Heparin and in 3 ml, 5 ml, and 10 ml sizes for Normal Saline. Consumers and user facilities with the Sierra Pre-Filled recalled pre-filled syringes or Heparin or Saline Lock Flush Solution USP, should stop using the products immediately.  Recalled products should be immediately quarantined in inventory and immediately returned to the distributor.  The product was distributed to Florida, Texas, Illinois, Colorado, and Pennsylvania.

Infections resulting from the Serratia marcescens can cause fever and chills and can be serious, but generally respond well to antibiotics.  In people with weakened immune systems, however, this type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.  Many of those using the tainted Sierra Pre-Filled syringes were undergoing chemotherapy treatments which would have compromised their immune systems.

An ongoing FDA inspection of Sierra Pre-Filled’s facility revealed the company is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

]]> Sierra Pre-Filled Syringe Recall Expanded http://www.yourlawyer.com/articles/read/13723 Mon, 21 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13723 Sierra Pre-Filled Syringes have been recalled due to concerns over potential bacterial contamination.  The Sierra Pre-filled Syringe recalls has now been expanded to include all lots and all sizes of both Heparin and Saline pre-filled flushes manufactured by Sierra Pre-Filled, Inc.—also known as AM2 PAT—located in Angier, North Carolina.  The Sierra Pre-Filled syringe products are distributed under two brand names:  Sierra Pre-Filled Inc. and B. Braun.  The products are sold in pre-filled syringes in 3 ml and 5 ml sizes for Heparin and in 3 ml, 5 ml, and 10 ml sizes for Normal Saline.  Heparin is a blood thinner and the syringes are used to clear out catheters and intravenous lines.  Consumers and user facilities with the Sierra Pre-Filled recalled pre-filled syringes or Heparin or Saline Lock Flush Solution USP, should stop using the products immediately.  Recalled products should be immediately quarantined in inventory and immediately returned to the distributor.

One lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes is confirmed to be contaminated with the Serratia marcescens bacteria and resulted in a number of patient infections.  Infections resulting from this bacteria can cause fever and chills and can be serious, but generally respond well to antibiotics; however, this type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.  

An ongoing Food and Drug Administration (FDA) inspection of Sierra Pre-Filled’s facility revealed that the company is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

This is not the first time Sierra Pre-Filled has been in the news in recent weeks.  The CDC began its investigation following reports of dozens of blood infections linked to contaminated medical syringes.  Around 40 people were sickened in Texas and Illinois, including 20 outpatients at the Rush University Medical Center in Chicago; no deaths were reported.  Of the 20 Rush outpatients who fell ill, 14 patients required hospitalization.  Doctors at Rush were able to trace the infections to heparin-filled syringes the patients used during home treatment for cancer and other ailments.

A leukemia patient—Katie Abrams, 30, of Buffalo Grove, Illinois—also filed a suit against Sierra Pre-Filled, Inc. when she claimed a batch of Sierra Pre-Filled heparin syringes contaminated with bacteria made her fall violently ill.  Abrams was hospitalized for nine days after using the Sierra Pre-Filled Syringes at home, when she "became ill with uncontrollable shaking, vomiting and a fever that reached as high as 105.5 degrees Fahrenheit," according to the complaint filed recently in that state’s court.

Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10am-5pm Eastern Standard Time.  Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

]]> Sierra Pre-Filled Syringe Lawsuit Filed in Illinois, and More are Expected to Follow http://www.yourlawyer.com/articles/read/13562 Wed, 26 Dec 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13562 Sierra Pre-Filled Syringe made a leukemia patient seriously ill, and now she is suing the maker of the defective devices.  The 30-year-old Illinois woman reportedly spent 9 days in the hospital as a result of the bacterial infection she contracted from the Sierra Pre-Filled Heparin Syringe she used as part of her home treatment.  Late last week, the tainted Sierra Pre-Filled Syringes where pulled from the market after dozens of blood infections where traced to them.  

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.  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 bacterium called Serratia marcescens found in a single batch of the heparin-filled syringes made in North Carolina, by a company called Sierra Pre-Filled.  Serratia marcascens generally causes fever, chills and vomiting, but responds well to antibiotics.  However, in cancer patients, the blood infection can be much more serious because the immune systems of such patients are already compromised.  In such cases, infections caused by the bacteria could be life-threatening,

The Food & Drug Administration (FDA) ordered the contaminated Sierra Pre-Filled Syringes recall late last week.  The FDA is asking doctors  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. 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”.

In what will likely be the first of many Sierra Pre-Filled Syringe lawsuits, the Buffalo Grove, Illinois leukemia patient alleges that she “became ill with uncontrollable shaking, vomiting and a fever that reached as high as 105.5 degrees Fahrenheit."  The complaint, which was filed in Illinois state court last Friday, is asking for unspecified damages.

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. Tainted Sierra Pre-Filled syringes from that batch were also sent to Colorado, Florida, and Pennsylvania but infections—so far—have turned up only in Illinois and Texas.]]> Sierra Pre-Filled Heparin Syringes Recalled After FDA Inspection Finds Problems with Companys Quality System http://www.yourlawyer.com/articles/read/13560 Tue, 25 Dec 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13560 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.

]]> Contaminated Sierra Pre-Filled Heparin Syringes Cause Bacterial Infections in 40 People, CDC Investigating http://www.yourlawyer.com/articles/read/13537 Thu, 20 Dec 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13537 Sierra Pre-filled syringes have made dozens of people in two states ill with a potentially serious bacterial infections.  The Centers for Disease Control and Prevention (CDC)  is investigating the illnesses, and the defective medical devices implicated in the infections have been pulled from the market.  

Around 40 people have been sickened in Texas and Illinois, including 20 outpatients at Rush University Medical Center in Chicago.  So far, no deaths have been reported, but 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 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 heperin-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).  

Taitned Sierra Pre-Filled 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 president of Sierra Pre-Filled, Dushyant Patel, said the company is working with both the CDC and the Food and Drug Administration (FDA) on the investigation and has voluntarily recalled the implicated lot. "There's nothing out there anymore," according to Patel.

The affected Sierra Pre-Filled syringes where from lot  070926H, Srinivasan said. He said the CDC is working to ensure doctors are alerted about the contamination; doctors and hospitals should be aware that more cases could surface. "Our highest priority is to ensure that all of those cases that occur are identified," he said. ”Patients who think they used affected syringes should contact their doctors,” Srinivasan said, adding, “We'll be working to perform genetic fingerprinting on the bacteria to confirm a link between bacteria in the syringes and the case patients.

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 twins appeared to be doing well, a lawyer for the Quaids said earlier this month.  Patel said the heparin in his company's pre-filled syringes comes from a different company.  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.

]]> Sierra Pre-Filled Syringes Bacterial Infections Lawsuit Lawyer / Attorney http://www.yourlawyer.com/topics/overview/Syringes_Linked_to_Bacterial_Infections Thu, 20 Dec 2007 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/Syringes_Linked_to_Bacterial_Infections

Sierra Pre-Filled Syringes

Keywords: Sierra | Syringe | Bacterial Infections | Lawsuit | Lawyer | Attorney

 Sierra Pre-Filled Heparin Syringes caused serious bacterial infections in at least 40 people in Texas and Illinois in December 2007.   The patients became infected by flushing their central intravenous catheter with the heparin-filled syringes.    Heparin is a blood thinner that prevents the formation of blood clots and is used to keep central intravenous lines from clotting.  Sierra Pre-Filled Syringes from the contaminated batch where also sent to Colorado, Florida, and Pennsylvania, prompting Sierra Pre-Filled to pull the defective syringes from the market.  The tainted syringes were manufactured by Sierra Pre-Filled, also known as AM2 PAT, of Angier, North Carolina.

Sierra Pre-Filled Syringes Linked to Bacterial Infections
Around 40 people in Texas and Illinois where sickened by the contaminated Sierra Pre-Filled Syringes.  The victims included 20 outpatients at Rush University Medical Center in Chicago.  No deaths have been reported related to the Sierra Pre-Filled Syringes, but of the 20 Rush outpatients who fell ill, 14 required hospitalization.
Doctors at Rush were able to trace the infections to Sierra Pre-Filled Syringes patients used during home treatment for cancer and other ailments.  The infections were the result of a bacterium called Serratia marcescens, which can cause fever and chills.

Tainted Sierra Pre-Filled Syringes Pulled Removed From Market
The infected Sierra Pre-Filled Syringes came from a single lot - 070926H –that was manufactured at the Sierra Pre-Filled manufacturing facility in North Carolina.   The bacteria were found in fluid from the Sierra Pre-Filled syringes, but it is uncertain if the original contamination was in the heparin, the saline used to dilute the drug, or the syringes themselves.  As a result of the bacterial contamination, all Sierra Pre-Filled syringes from the implicated lot where recalled.

Legal Help
If you or a loved one has been injured by a contaminated Sierra Pre-Filled syringe, you may have valuable legal rights.  Please fill out the form at the right for a free case review by a qualified attorney.]]>