Sierra Heparin Lock Flush
|
Syringes used to flush IV lines (PICC lines and metaports) and are frequently utilized by patients with long-term or permanent IV lines related to an underlying condition – are the mostly likely individuals that would have contact with this product.
A handful of companies manufacture pre-filled Heparin syringe to flush IV lines. The company that has now issued this recall on the following contaminated lot is commonly known as Sierra or Sierra Pre-Filled and is also known as AM2 Pat, Inc.
RECALLED LOT: The syringes manufactured by Sierra are referenced under lot # 070926H.
This lot was distributed from mid-November through mid to late December 2007.
Sample Tests – Have now confirmed that the lot is contaminated with the bacteria Serratia Marcescens. The lot was distributed primarily to Texas, Florida, Illinois, Colorado, and Pennsylvania.
Sierra does not manufacture the Heparin contained in its syringes.
ALERT: On December 20, 2007, Sierra initiated a nationwide recall of the Heparin Lock Flush Syringes, lot #070926H after the CDC confirmed the contamination of samples within the lot with Serratia marcescens.
The FDA has since inspected the Sierra Facility that manufactured lot #070926H and has determined that the facility was “not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.”
The FDA approved the Sierra Heparin Lock Flush syringe in 2003, classifying it as a Class II device subject to special controls. Those controls include the Quality Systems regulation located in 21 CFR 820, et seq., which sets forth the current good manufacturing practice requirements, including requirements related to contamination control, maintenance, inspection, handling, and storage.
The FDA has highlighted Sierra’s failure to comply with these regulations, but has not specified which regulations were violated. Sierra has reportedly claimed that the batch of syringes went through eight different tests and the sterility was independently confirmed before the syringes were shipped.
The link between Sierra syringes and Serratia marcesens contamination was discovered as early as December 5th by epidemiologists at Rush University Medical Center in Chicago after an outbreak of infection in 20 patients in Rush’s oncology center. One report notes that Sierra began withdrawing the product from the market and contacting patients as early as December 5th, and may have attempted to quarantine the product as early as November 27th by instructing distributors not to release the product. The focus of Sierra’s initial efforts to remove the syringes focused only on Illinois and Texas. On December 18, 2007, the president of Am2 Pat, Inc./Sierra stated that “there’s nothing out there anymore” in relation to the contaminated syringes. Two days later, the company initiated the nationwide recall.
UPDATE: On January 18, 2007, AM2 Pat, Inc. expanded the nationwide recall to include all lots of Heparin and Saline flushes manufactured by the company. The products are marketed under the names Sierra Pre-Filled, Am2 Pat, Inc., and B. Braun.
These products will all be marked with the National Drug Code (NDC) Prefix of 64054. The expanded recall cites the earlier contaminated lot of Heparin Flush syringes as the reason for the recall.
TRADEMARK NOTICE: Heparin Lock Flush and Baxter Heparin are trademarks of Sierra, Inc. and Baxter International Inc. accordingly.
The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Sierra, Inc. and Baxter International Inc. The use of this mark is solely for informational and product identification purposes.
