Contaminated Heparin Syringes

Health officials are investigating cases of people across the country getting sick after being exposed to dangerous bacteria that contaminated heparin-filled syringes in several states. The syringes are used by patients for the home treatment of cancer and other sicknesses. Heparin is a blood thinner; in the case of these contaminated syringes, the drug is used to clear out catheters and IV lines after they have been used to treat sick patients.

The contaminated syringes contain a bacteria called Serratia marcescens (Sur-AY’-she-uh mar-SUH’-sens) and are made by Sierra Pre-Filled Corp. of Angier, N.C. The lot number of affected batches is 070926H. Syringes produced by AM2 PAT Inc. have also been recalled.

Update: 2/26/09: According to an Associated Press article, AM2PAT Inc. was investigated and found grossly negligent in their behavior, hygiene, and manufacturing standards. The Associated Press reports, “Federal investigators contend that the company was so consumed with maximizing profits that it shipped syringes filled with saline and the blood-thinner heparin from a dingy facility without ensuring they were sterile. Some reported orange specks floating around in unopened syringes, while others reported yellow sediment or muddy brown syringes filled with floating white specks.”

Update: 12/20/07 The FDA says, "AM2 PAT, Inc., Angier, North Carolina, is initiating a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes have been found to be contaminated with Serratia marcescens, which have resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product.

Update: Nationwide Recall: A nationwide recall has been enacted for all lots of both Heparin and Saline pre-filled flushes sold under the brand names of Sierra Pre-Filled, Inc. and B. Braun. Syringes have been confirmed as having the Serratia marcescens bacteria in them, which according to the FDA “could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.”
Source: AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes from www.FDA.gov.

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Consumers and user facilities who have these recalled pre-filled syringes, Heparin Lock Flush Solution USP, should stop using the product immediately. Please quarantine the affected product in your inventory and return it to your distributor immediately."
From: AM2 PAT, Inc. Issues Nationwide Recall of Pre-Filled Heparin Lock Flush Solution, accessed 12/20/07 via www.fda.gov.

Infections of Serratia marcescens can be very serious and cause high fevers and chills. The bacteria can usually be found in the urinary and respiratory tracts of hospitalized adults and health officials are unsure as to how the heparin-filled syringes became contaminated. Most of the people who were infected with the bacteria had to be hospitalized. If children are infected, meningitis can result.

Exposure to the dangerous syringes occurred between mid-November and the first week of December 2007. The syringes were from a batch that was sent to Colorado, Florida, and Pennsylvania. Infections were first reported in Texas and Illinois, where 20 patients of Rush Medical Center in Chicago became ill.

The tainted syringes have been recalled, but if you or someone you care about used a heparin-filled syringe and became sick afterwards, call our lawyers immediately. We have decades of experience handling claims when innocent victims suffer because of the negligence of others.

Source: Bacteria-Tainted Syringes Sicken Dozens, from the Associated Press. Published 12/19/07, accessed 12/20/07 via www.cbsnews.com.