Why did Baxter Recall Heparin Lots? What is Baxter Recall History?

According to the Baxter Healthcare website, the company is a leader in healthcare and has been for the past 75 years. The company assists healthcare professionals and their patients with complex medical issues. Blood thinners or anticoagulant drugs like Heparin would fall into that category.

Baxter Healthcare also has achieved record earnings and sales in 2007. For the fourth quarter, Baxter Healthcare reported net income of $478 million. On an adjusted basis, Baxter Healthcare reported net income of $488 million, an increase of 13 percent over the same period last year.

2007 was a very successful year for Baxter Healthcare; they met or exceeded financial expectations and according to their website -- progress has been made in "accelerating innovation".

Yet, heparin multi-dose vials are not the first Baxter Healthcare recall. More Baxter Healthcare recalls include:

In September 19, 2005, all models of Baxter Healthcare Corp COLLEAGUE© Volumetric Infusion Pumps. Affected Models were: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R were recalled because the batteries were known to swell or deliver excessive discharges causing interruption or prevention of therapy resulting in serious injury or possible death to patients.

The infusion pumps were used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream.

In December 15, 2005, another recall outlined more problems with the COLLEAGUE© Volumetric Infusion Pumps such as the battery undercharging, false air detection alarms, worn parts of the pump’s motor can shut down and interrupt therapy, insufficient fluid delivery, improper venting.

(These medical products cost thousands of dollars. Is there no quality control or checks and balances?)

Recall initiated on October 28, 2005-Baxter Healthcare Corporation has received reports from users of the ALYX Component Collection System of leaks from the cassette of the disposable kit. Such leaks have a potential to create a breach of the sterile pathway within the cassette with a theoretical risk of bacteremia to donors if there has been blood returned to the donor before the leak was detected.

Recall initiated on March 16, 2005 for 16 models of Blood-Pack Unit with Samplink Access Device Product Code 4R1247MC. Baxter has determined that expired Samplink access devices were included in cases of Blood-Pack Unit, Product Code Number 4R1247MC (the Blood-Pack Units were not expired). Baxter will no longer supply the Samplink access device along with the Blood-Pack Units product in the same finished goods carton. The Blood-Pack Units product and the Samplink will be shipped in separate containers.

Recall initiated March 16, 2005 for Amicus Separator, product codes 4R4580 and 4R4580R, call serial numbers because Baxter redesigned the AMICUS SEPARATOR Instrument centrifuge window to withstand ammonia cleaning; however it is Baxter's recommendation that ammonia and ammonia based cleaners NOT be used to clean any part of the AMICUS SEPARATOR Instrument. Instead, a mild soap/detergent is recommended.

Recall initiated on March 15, 2005 for Platelet Bedside Filter Product Code Number 4C2496 Lot Number - A04I08265 because Baxter has determined that the pre-filter on Platelet Bedside Filter sets were assembled in the inverted orientation.

Recall initiated July 21, 2004 for Amicus Separator apheresis device, product codes 4R4580 and 4R4580R, installed with software version 2.51 because Baxter Healthcare Corporation received four user reports that the Amicus Separator collected more plasma in the course of an apheresis procedure than desired or collected plasma when none was targeted. In all cases, the error occurred during the single needle platelet collection procedure with the concurrent collection of red blood cells, and the devices had software version 2.51 installed. Baxter determined that the method used by software version 2.51 to calculate plasma collected at various points during the procedure can be optimized. The firm plans to release a new software version that will return all excess plasma collected during reinfusion at a controlled rate determined by the donor's weight.

Recall initialed June 24, 2004 for Immune Globulin Intravenous (Human), GAMMAGARD S/D, 10 gm; lot number LE08D030AA with an expiration date of 3/30/2006 because there has been an increased frequency of adverse event reports of allergic reactions associated with this lot. Although none of these reactions have been life threatening, two reported reactions involved the airway, and all reactions required medical intervention. The firm requests the use of this lot be immediately discontinued, and the affected product be returned to the manufacturer.

Recall of Triple Blood-Pack Unit with PL 732 Transfer Pack date initiated March 17, 2003 lot number M03A09014 expiration date 9/30/2004, lot number M03A09014A 9/30/2004 Baxter Healthcare became aware of leaks involving the PL 732 platelet container during component preparation The reported leaks occurred during expression of plasma from the platelet container. Blood products successfully processed in containers that did not split are not affected.

Recall of Blood-Pack Unit with PL 732 Transfer Pack recall initiated November 11, 2002 for nine lot numbers expiring 9/30/03, one lot number expired 2/29/04, 13 lot numbers expiring 3/31/04, four lot numbers expiring 5/31/04, and nine lot numbers expiring on 4/30/04. The reason was Baxter Health Care has become aware of the splitting of the platelet container during component preparation. This has only been observed during centrifugation or expression of plasma, in which the split occurs near the side of the container. The blood products that have been successfully processed in the containers that did not split are not affected.

Recall of Automated Blood Cell Separators, Baxter Fenwal, Open and Closed System Apheresis Kits with a recall initiated on May 7, 2002 for three apheresis kits with different lot numbers because Baxter Healthcare Corporation has become aware of a restriction in the Y-site located above the separation container that can cause pressure alarms during priming of the Apheresis Kit and possibly during the collection procedure. This restriction may damage red cell during the collection procedure. The CS-3000 Blood Cell Separator is designed to alarm when pressure restrictions occur during priming or the collection procedure. These alarms alert the CS-3000 Operator of a restriction within the Apheresis Kit. The potential issues associated with this restriction are alarms during priming and collection, difficulty completing a procedure, and impaired red blood cell flow. The flow restriction through the Y-site would affect a small number of Apheresis Kits and would be apparent to the CS-3000 operator via alarms during the priming and run procedures. Consignees have been asked to contact the manufacturer to arrange for product return.

Recall initiated on July 18, 2001 of Albumin (Human) 5%, Buminate because a subsequent to release of this product Baxter performed a non-required PCR test of the plasma manufacturing pool from which this product was derived. A low-level positive PCR test result for HIV-2 was obtained for the fourth centrifugation run of the plasma manufacturing pool. The manufacturing process includes steps for viral inactivation. No adverse events associated with this specific lot have been reported.

Recall initiated on May 31, 2001 of Amicus Separator Operating with Version 2.50 Software because Amicus Separators operating with version 2.50 software after discovering that the device may return an inappropriate volume of plasma to a donor during an apheresis procedure. This occurrence has been observed during single needle procedures using Amicusâ Separators operating with Version 2.50 software in which the 'inlet line occlusion auto restart feature' (auto restart) is turned "ON". Individuals may experience clinical symptoms of citrate related toxicity and/or fluid overload as a result of the problem. See above, Baxter Healthcare had a later recall for the version 2.51 software.

Voluntary recall on October 24, 2000 of Immune Globulin Intravenous (Human) Iveegam EN with one lot number that expired 11/30/2001 because Dissolution of the product, with the supplied Sterile Water for Injection, exceeded the 10 minute product specification.

The Baxter Healthcare Recalls don’t stop here. The FDA website demonstrates many more recalls covering 2000 and into the mid 1990s. The point is: Why so many Baxter Healthcare recalls?

If you or a loved one is a victim of the heparin blood thinner multi-dose vial or the combination of single heparin dose vials – then you need a wrongful death or personal injury law firm by your side.

Consider the support and services of Anapol Schwartz law firm with offices in Philadelphia, Reading, Media, and Harrisburg, PA and Cherry Hill, NJ. Please contact us for your free legal consultation today.