March 12, 2013 — The U.S. Food and Drug Administration (FDA) has sent Stryker Corp. a warning letter related to concerns about quality control at its Portage, Michigan facility, in response to observations made during an inspection in November 2012. The warning letter also noted that Stryker failed to notify the FDA of a product recall, though they did not specify what product was recalled, and for marketing medical devices without receiving proper clearance from the FDA. Stryker has already responded with a corrective action plan, according to the press release issued today.
One of the devices that Stryker marketed improperly was the Neptune Waste Management System, which was sold without a required 510(k) clearance. The 510(k) approval allows new products that are “substantially equivalent” to approved products to be sold without going through rigorous clinical trials.
Stryker issued a Class I recall of the Neptune Waste Management System in June 2012, after the company received two reports of serious injuries, including one fatality. The fatality occurred when a customer connected the high-powered suction device to a patient’s passive chest drainage tube after an operation. The recall was initiated because the product did not specifically warn against connecting the vacuum to a passive drainage tube.
When the Neptune products were recalled, the FDA warned:
“FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used.”
Stryker said they are “fully cooperating with the FDA to resolve these matters in a comprehensive and timely manner.”
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