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July 28, 2014
7 Min Read
Updated August 21, 2014There has been plenty of news recently when it comes to serious medical device errors-- from moldy infant head cradlers to GE Healthcare carbon dioxide detectors with potentially incorrect values to Medtronic's recall of a cerebrospinal fluid draining and monitoring deviceAnd unfortunately, in the case of General Electric and Medtronic, these were companies that had seen their share of Class I-level recalls in recent years.Read on to find out more:
1. Moldy Infant Head Cradlers
The FDA has issues a Class I designation for Philips Healthcare's voluntary recall of Gel-E Donut and Squishon 2 gel-filled products--used in hospitals to support and cradle an infant's head and/or body.
Gel-E Donut products, as shown in a Philips Healthcare brochure.
Philips' Children's Medical Ventures subsidiary in Monroeville, PA, recalled the products after receiving a number of complaints about visible mold on the outer surface. Further investigation found the mold to be Cladosporium and Penicillium Fungi, commonly found molds that nevertheless could be deadly for infant, causing infections as well as allergic reactions and difficulty breathing. The affected Gel-E Donut and Squishon 2 products were made and distributed from July 1, 2012 to December 31, 2013.Read the FDA's announcement.
2. An Intranasal Splint Gel That May Not Have Correct Acid Concentrations
FDA officials are increasingly raising concerns about Enhancement Medical's Expression, a hyaluronic acid gel that is packaged in a syringe and listed with the FDA as an intranasal splint to minimize bleeding and swelling inside the nasal cavity after trauma or surgery.
Expression syringe, as shown on Enhancement Medical's website
The agency on August 14 placed a Class I designation on Wauwatosa, WI-based Enhancement Medical's recall of all lots of Expression after it could not ensure that Expression contains the correct concentration of hyaluronic acid.Enhancement Medical last year asked customers to return certain lots of the Expression after receiving multiple complaints documenting adverse events including swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules--all after subcutaneous injection. The company's further investigation found hyper-concentrated lots of the Expression, according to the FDA.The FDA has also received reports of Expression being used as a dermal filler to fill in wrinkles on the face--an unapproved use.For Expression, Enhancement Medical utilizes hyaluronic acid produced by Denmark-based company Novozymes Biopolymer. The Danish company touts its hyaluronic acid as superior because no animal-derived raw materials are used to make it, so there is no risk of viral contamination or of transmittance of animal spongiform encephalopathy.Older methods derive the acid from rooster combs or microbial fermentation of media containing yeast or animal extracts. The Novozymes hyaluronic acid that Enhancement Medical uses is produced through fermentation of a sucrose-based medium by a novel and non-pathogenic strain, Bacillus subtilis.Read the FDA's announcement.
3. A Cutting Tool That Could Leave Sheath Fragments in Blood Vessels
Made by Cardiovascular System, the Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool inserted via a catheter through the skin into a patient's blood vessel. It is meant to reestablish blood flow in narrowed arteries or arterio-venous dialysis shunts. However, New Brighton, MN-based Cardiovascular Systems recently announced a recall involving certain lots of the Diamondback because they may contain defective saline sheaths that could fracture during use. The FDA on August 19 designated the recall as Class I because of the danger of blood vessel blockage. To date, there are no reported patient injuries, according to the FDA.Read the FDA's announcement.
4. GE Hit with Another Class I--This Time over Carbon Dioxide Detectors
The FDA on July 25 designated a GE Healthcare voluntary recall of carbon dioxide detectors as Class I.The products--Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC)--may fail or provide incorrect carbon dioxide values for mechanically and spontaneous ventilated patients, the FDA said in its announcement. Such a malfunction could cause physicians to decisions with life-threatening consequences for patients, including hypoventilation. There are no reports of injuries or deaths associated with the malfunctioned devices, according to the FDA.The modules were manufactured between February 10, 2012 and October 2, 2012, and distributed between February 2012 and April 2014. This is General Electric's ninth Class I-level recall since the start of 2012. Only Johnson & Johnson and CareFusion have had more serious recalls. Medtronic is presently tied with GE.Read the FDA's announcement.
5. Another Class I Recall for Medtronic
Medtronic Duet External Drainage and Monitoring System
The FDA recently designated Medtronic's voluntary recall of a cerebrospinal fluid draining and monitoring device as Class I.Officials at the agency think that the recalled Medtronic Duet External Drainage and Monitoring System could cause serious injury or death because the patient line tubing may separate from the patient line connectors during frequent handling.Such a device failure could result in air within the skull (pneumocephalus), infection such as meningitis, ventriculitis, encephalitis, and over and under drainage of the cerebrospinal fluid, according to the FDA.This is also Medtronic's ninth Class I-level recall since the start of 2012. Medtronic says there have been no permanent serious injuries or deaths connected with the Duet recall.Read Qmed's story about the recall.
6. Resuscitator Bag with a Sticking Valve
Ventlab (Grand Rapids, MI) is voluntarily recalling manual resuscitator bags because a duckbill valve may stick and prevent air from getting to the patient, the FDA and the company announced. One injury has been reported due to a stuck valve, which can prevent oxygen from reaching tissues--slowing breathing and even leading to death. The company received 31 reports of a delay in oxygenation. The sticking may be the result of inadequate curing in the manufacturing process.The Class I-level recall affects devices that were manufactured and distributed from January 10, 2013 through July 1, 2013 and are made for medical personnel use only. The trade names for the recalled bags include Airflow Bag, Breath Tech Bag, Provider Bag, STAT-Check Bag, Safe Spot Bag, V-Care Bag, Medline Bag, RescuMed Bag, VT1000 Kit.Read Qmed's story about the recall.
7. A Catheter with Separation Issues
A VentLab VN5000 series resuscitator bag, as shown on the company's website. It's one of the product series involved in the recall.
The FDA in July also announced a Class I designation for Vascular Solutions' recall of its Langston V2 Dual Lumen Pressure Monitoring Catheter.Health practitioners use the device to deliver dye, or contrast medium, into a patient's blood vessels during medical imaging tests; the device also measures pressure within the blood vessel.FDA officials think the recalled catheters could cause serious injury or death because Vascular Solutions received reports that the inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub while in use. In such cases, a procedure may be needed to retrieve the separated piece from the patient's vascular system.Read Qmed's story about the recall.
Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.
8. Labeling Error Sparks Glucose Test Strips Recall
For the second time this year, a recall involving glucose test strips has received a Class I designation from the FDA.The Class I-level incident, which the FDA announced this month, involves Dorado, Puerto Rico-based Diabetic Supply of Suncoast's voluntary recall of Advocate Redi-Code+ BMB-BA006A blood glucose test strips manufactured by BroadMaster Bio-Tech Corp. of Taiwan.The Diabetic Supply of Suncoast recall comes about seven months after the FDA said Abbott Laboratories' FreeStyle and FreeStyle Lite test strips could cause serious injury or death because they were found to provide inaccurate readings of blood glucose when used with the FreeStyle and FreeStyle Flash meters and the Insulet OmniPod. (The FreeStyle and FreeStyle Flash devices have not been produced since 2010.)In the case of the Suncoast recall, the issues involves a labeling error omitting the test strips model number (BMB-BA006A). According to the FDA and Suncoast, this could potentially lead to use of the Advocate Redi-Code+ BMB-BA006A blood glucose test strips with incorrect glucose meters made by Taidoc Technology Corp. Misuse could result in incorrect glucose test results--a life-threatening situation for a diabetic.Read Qmed's story about the recall.
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