EXPANDED RECALL ALERT:
Florida residents beware: the nationwide recall on pre-filled heparin flush syringes and viles manufactured by Am2Pat, Inc. d/b/a Sierra Pre-filled and B. Braun Medical, Inc., due to contamination with the Serratia marcescens bacteria, has been expanded. Unfortunately; for many patients using this dangerous and defective drug, the recall was too late. Several reported cases of the infection were in Florida as well as in other states. The Food and drug Administration (FDA) warned that patients and clinicians should immediately stop using these products.
On January 25, 2008, the U.S. Food and Drug Administration issued a class 1 recall of Sierra heparin or saline pre-filled syringes. A class 1 recall is the FDA’s most serious and is reserved for those situations where using the defective product “will cause serious injury or death.”
This FDA recall expanded upon a Dec. 20, 2007 recall by Manufacturer, Am2Pat, Inc. which targeted only one lot of the pre-filled heparin syringes that were contaminated with Serratia marcescens bacteria. The FDA has since broadened the recall after receiving reports of additional infections linked to Sierra’s pre-filled saline syringes as well.
State health departments have been notified by the CDC that Am2Pat intends to extend the recall of its prefilled heparin and saline flush syringes to encompass all distributed lots of these products because of concerns these syringes may be contaminated with the gram-negative bacteria, Serratia marcescens.
These syringes were manufactured by Am2Pat and may be labeled as: Am2Pat, Sierra Pre-filled, or B. Braun. All of these products will bear the National Drug Code or NDC prefix of: 64054.
These products have been distributed to in-patient and out-patient facilities and directly to patients by home-care companies such as Maryland based Caremax Medical resources, LLC.
In a seperate notice, heparin products manufactured by Baxter were also recalled due to contamination.
Anyone having questions regarding the manufacturer of prefilled syringes they are using should call the FDA and should save the packaging to help identify the distributor company that provided the syringes.
Health care practitioners identifying cases of Serratia bloodstream infections among patients who might have been exposed to these products are urged to report these cases to their local health department.
Local health departments identifying cases of Serratia bloodstream infections potentially related to the recalled products should report the information to their state health departments.
Manufacturers and the distributors of dangerous or defective products like these tainted pre-filled syringes are liable for any injuries caused by their products under state and federal product liability laws. Our firm is currently representing families of Florida patients who have been infected by these contaminated syringes. We are hopeful that our efforts will deter this kind of irresponsible corporate behavior and help to obtain substantial compensation for the victims and their families. For more information on this dangerous pharmaceutical product, view the original FDA recall on our web site.