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CORDIS REPORTS SEC FILINGS

 CORDIS REPORTS SEC FILINGS
 MIAMI, May 11 /PRNewswire/ -- Cordis Corporation (NASDAQ: CORD)


announced the filing with the Securities and Exchange Commission of a Form 8-K dealing with two interrelated regulatory matters focusing on the company's French-based neuroscience operations.
 The first relates to the possible issuance, by FDA, of an order under section 518(a) of the Food, Drug and Cosmetic Act, pertaining to the company's recent voluntary recall of certain Hakim valves and accessories that contain a specific lot of potentially defective right angle connectors. The order, which Cordis is appealing, could require the company to undertake certain measures to notify physicians or patents of potential risk.
 Such action is inconsistent, the company said, in light of the FDA's classification of the recall as a Class II action (i.e., temporary or medically reversible with remote probability of serious consequences) and of the fact that, since January 1988 when the single production lot of connectors was first used, Cordis has received just one report of a fractured connector. Cordis said that a meeting to discuss the agency's proposed action is set for later this week.
 The second issue concerns a warning letter from the agency to the company's neuroscience manufacturing facility in France. That letter, which includes a ban on imports into the U.S. of all devices manufactured by the facility, was the outgrowth of a routine inspection of the plant in January that cited a small number of possible violations of good manufacturing practices.
 Cordis said that corrective action plans were described in a written report to FDA within two weeks of that inspection. The agency has requested additional documentation to support the implementation of these changes, which the company is in the process of assembling.
 Cordis said it is doing everything possible to expedite the resolution of the import restriction and to minimize any impact resulting from the regulatory actions. With U.S. neuroscience sales accounting for less than 3 percent of worldwide revenues in the latest quarter, the company said it is unlikely that the actions will have a material effect on its financial condition going forward.
 Daniel G. Hall, the company's vice president of legal affairs and general counsel, indicated that the FDA has issued some 30-such warning letters in the past six months to foreign manufacturing facilities producing products for distribution in the U.S. "It appears that we are witnessing a significant change in the agency's enforcement activities and posture as they relate to medical devices produced by foreign-based operations," he said.
 Miami-based Cordis Corporation manufactures and markets a variety of medical devices and systems for the angiographic and neuroscience markets. The company operates major production facilities in the U.S., The Netherlands and France.
 -0- 5/11/92
 /CONTACT: Chick McDowell, vice president of corporate relations and assistant secretary of Cordis Corporation, 305-824-2821/
 (CORD) CO: Cordis Corporation ST: Florida IN: HEA SU:


AW-JB -- FL017 -- 8764 05/11/92 16:07 EDT
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Date:May 11, 1992
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