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FDA: Manufacturers Not Making Progress In Improving Recall Notifications

This article was originally published in The Silver Sheet

Executive Summary

MANUFACTURER RECALL NOTIFICATIONS LACK SPECIFIC INFORMATION that could help customers, FDA says. Too often, recall letters "are soft-pedaled or there's clearly not adequate information about risk," says Cap Uldriks, CDRH associate director for regulatory guidance and government affairs. A recent review by TJR Consulting Services of 20 random device-related recall letters found that many firms fail to include basic information, including the classification of the recall, manufacturer contacts and information on possible adverse effects. "Almost all of the recall notices that I get truly are incomplete," says Bea Haupt, recall & safety manager for Inova Health System, who says she wants "to see all three of these in a recall notice: the adverse effects statement, information on whether the government has knowledge of the recall, and the potential hazards." Also in this issue, Medtronic and Cordis officials explain their approaches to recall notices

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