Every year, the Food and Drug Administration (FDA), as well as other companies, issue medical device and medication recalls that affect millions of patients. Although efforts are made to contact patients and providers, there are cases where the recall messages do not reach those who need to receive it. There has been a slew of major recalls over the past few years, including popular devices and a common blood pressure medication.
Nine out of the ten biggest global medical device recalls are Class I, which present the most significant public health risks. The following list includes the medical devices, as well as the number of units, recalled:
West Pharmaceutical’s fluid transfer system is used to connect medication vials to intravenous bags. It mixes the medication before it is administered to patients. The Vial2Bag’s 13mm device affected pregnant women who were given oxytocin during delivery. This was possibly due to the medicine being transferred incorrectly from vials to bags, causing under or overdosing. Sixteen complaints were received by the FDA, and the 38.8 million units were recalled last January.
Magellan Diagnostics’ LeadCare and the LeadCare II testing systems were recalled due to the inaccurate test results they were providing. Both detect how much lead is in blood samples taken from patient veins. They use electrochemical tests and disposable sensors with finger stick tests. If inaccurate blood lead levels are shown, patients could receive inappropriate and dangerous treatment from providers.
With recalls in the millions, Cook Medical’s Beacon® Tip technology catheters were voluntarily recalled. According to complaints, the units’ catheter tips were fracturing and separating due to polymer degradation. This could make these devices stop working, and the tips could have entered patients’ bloodstreams.
The FDA has been recalling Valsartan medications, which are used to control blood pressure and lessen the risk for heart failure. This started in July 2018, when it was found that the drugs had cancer-causing agents called NDEA and NDMA. These were both shown to have carcinogenic properties by the U.S. Environmental Protection Agency.
The recall has been expanded since different manufacturers, such as Aurobindo Pharma USA, Zhejiang Huahai Pharmaceutical, and Torrent Pharmaceuticals produce Valsartan. Although the exact cancer risk for pills contaminated with NDEA and NDMA is unknown, the FDA recommends that patients taking Valsartan switch to another medication.
With so many different product recalls, it is not surprising that patients end up concerned or confused. Reach out to a knowledgeable Philadelphia defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler for sound legal guidance regarding medical device or medication recalls. Complete our online form for a free case evaluation or call us at 215-569-4000. Located in Philadelphia, we serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.