Custom-made Cranial Implant Kits made by Stryker Corp. have been recalled over sterility issues.  According to the Food & Drug Administration (FDA), the Cranial Implant Kits are used to correct defects in the jaw and face, or cranium and face.

The Stryker cranial implant kit recall has been deemed a Class I recall by the FDA.  Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death, the agency said. (more…)

A Class I recall has been issued for laryngoscope blades distributed by Sun Med of Largo, Florida.  The Food & Drug Administration (FDA) issues Class I recalls when there is a reasonable probability that the use of a device will cause adverse health consequences or death.

The Sun Med laryngoscope recall involves Greenline/D MacIntosh No. 3 Laryngoscope Blades.  The product is labeled “Greenline/D MacIntosh No. 3 Laryngoscope Blades, Sterile and Disposable, Contents 20/box.”  This recall only involves lot codes Gj and Ha. (more…)

Federal regulators have announced a Class I recall of two unapproved medical devices.  The recall involves Vibrational Integrated Bio-photonic Energizer (VIBE device) sold by VIBE Technologies of Greeley, CO and the HLX8 device marketed by Nebion LLC of Los Angeles, Calif.  According to the agency’s recall notice, neither VIBE Technologies nor Nebion has demonstrated to the FDA that these devices are safe and effective at curing or treating diseases as claimed.

A Class I recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.  According to the FDA, VIBE and Nebion both claimed their devices treated conditions ranging from cancer to migraines. The agency  is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death. (more…)

Integra NeuroSciences is recalling Gravity Compensating Accessories used with brain shunting systems.  According to the Food & Drug Administration (FDA)  notice, the Gravity Compensating Accessory recall is a Class I recall – the agency’s most serious type.

A shunt is a tube that is placed in one of the fluid-filled chambers inside the brain. When infection or disease causes an excess of cerebrospinal fluid in the ventricles, the shunt is placed to drain the excess fluid to the abdomen. When working properly, the Gravity Compensating Accessory prevents fluid from being redirected from the brain while sitting or standing (more…)

Advanced Medical Optics (AMO) has announced a Class I recall of its Healon D Ophthalmic Viscosurgical Device (OVD) because of a contamination issue.  According to the Food & Drug Administration (FDA), some physicians who used a Healon D OVD during eye surgery observed an inflammatory reaction in their patients at the one-day post-operative visit.

The AMO Healon D OVD recall involved one lot of 30 mg/mL fill size syringes, labeled with “Lot Number UD30654 AMO Healon D Ophthalmic Viscosurgical Device”.  The device was manufactured from September 1, 2008 through September 30, 2008 and distributed from September 1, 2008 through October 29, 2008. (more…)

ReliOn Insulin Syringes used by diabetics have been recalled by Tyco Healthcare Group LP (Covidien).   The Food & Drug Administration (FDA) said the syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall involves one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles that may be mislabeled.  The recall applies to the following lot number and product information: (more…)

A defective Medtronic catheter used in the company’s implantable intrathecal pain pumps has been linked to the death of one patient.  In June, the company alerted doctors to the problem, but now, the Food & Drug Administration (FDA) has classified  Medtronic’s catheter safety alert a Class I recall.  Such a recall is defined as a situation in which there is a reasonable probability that the use of the product will cause injury or death.

Medtronic’s intrathecal drug delivery systems consist of an implantable pump and catheter that deliver small quantities of drug directly into the intrathecal space in the spine.  These devices are used to treat chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin. The Medtronic catheter recall involves the following models:  INDURA 1P Intrathecal Catheter, model 8709SC, Intrathecal Catheter, model 8731SC, Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC.   (more…)

Sage Products Inc. has issued a recall of some lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation because it could be contaminated with the bacteria Burkholderia cepacia (B. cepacia). Customers who have these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement.

According to the company’s recall notice, the defective product was shipped to U.S. hospitals and medical centers nationwide between April 28 and June 19,2008. This voluntary recall of Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation, is limited to the Product Code Numbers and corresponding Lot Numbers listed below:

Product Code Lot Number
9705             10722
9705             10729
9706             10718
9707             10357
9707             10365
9707             10641
9707             10672
9707             10753
9707             10755
9707             10944

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF. The intended application of the 2% CHG Cloth product is topical, for the skin only, and is not for oral or internal use. So far no illnesses have been reported in relation to this recalled device.

B cepacia has been implicated in product recalls in the past. In May, Hydrox Labs in Elgin, Illinois issued a voluntary recall of Cardinal Health-labeled alcohol-free mouthwash due to contamination with the bacteria. In 2005, the Centers for Disease Control (CDC) was notified by several states of clusters of pneumonia and other infections caused by B. cepacia and associated with contaminated mouthwash. In 2004, the CDC was notified of a voluntary recall of over-the-counter nasal spray due to contamination with B. cepacia complex.

In order to prevent this situation in the future, Sage Products has stopped accepting shipments of bulk 2% CHG solution from its outside supplier. The company says new product will be available for shipment as soon as July 7, 2008.

Faulty Ford cruise control switches are the subject of yet another consumer safety warning.  Thursday, the government warned owners of about 4.6 million recalled Ford vehicles to bring their cars and trucks in immediately to dealerships to disconnect the cruise control switch systems because they have been linked to engine fires.  The National Highway Traffic Safety Administration (NHTSA) issued the consumer advisory to owners of some Ford, Lincoln, and Mercury sport utility vehicles, pickup trucks, vans, and passenger cars that have not yet been repaired as the owners have not yet responded to past recalls.  The recalls affect Ford’s popular F-Series pickup trucks, prompting hundreds of complaints and dozens of lawsuits over engine fires. Three deaths have been connected to the fires and Ford has struggled to produce enough parts to correct the problem.

About 9.6 million Ford vehicles have been recalled since 1999 and about five million have been fixed, raising concerns about the remaining vehicles on the road, between four and five million. NHTSA said they have received approximately 60 complaints of engine fires in the Ford vehicles since August 2007.  Ford said they supported the action and dealers would soon offer a more permanent fix.  “We absolutely want everybody to come in as soon as they can because we can eliminate the risk of fire for anyone with a vehicle in this recall,” said Ford Motor Co. spokesman Wes Sherwood. He said the company would have an “ample supply” of the replacement parts by June. (more…)

Sierra Pre-Filled bacteria tainted syringes continue to be the target of lawsuits. Five people filed a lawsuit Thursday against Sierra Pre-Filled of Angier, North Carolina, manufacturer of the contaminated pre-filled syringes. All five claimants are Illinois residents and patients at Rush University Medical Center in Chicago. The five 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. (more…)