Rita Medical recall
This article was originally published in The Gray Sheet
Executive Summary
U.S. shipments of the Aug. 15-approved Habib 4x resection are being voluntarily recalled due to compromised sterile packaging, the company announced Sept. 27. The action will halt shipments of the electrosurgical product - which is manufactured in the U.K. by EMcision - until new packaging is designed worldwide. U.S. distributor Rita Medical expects to be back on track and meet demand by the firm's fourth quarter of 2005, but expects to realize "nominal revenue" during the third quarter from this product...
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