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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Lateral biopsy plate		see related information
Date Posted February 15, 2007
Recall Number Z-0517-2007
Product The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is labeled in part: Lateral Biopsy Plate, part 2414346, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils during Magnetic Resonance breast biopsy procedures. The lateral biopsy plate is packaged and sold as a part of catalogue E8800BG, M3087JG, G3087JH, M3335LA.
Code Information All lot codes.
Recalling Firm/
Manufacturer		 USA Instruments Incorporated
1515 Danner Dr
Aurora, Ohio 44202-9273
For Additional Information Contact Robert B. Smith
800-582-2145
Reason for
Recall		 The packaging used for the Breast Biopsy plate may exhibit small holes or tears
Action The recalling firm notified consignees via certified letter, dated 1/31/07.
Quantity in Commerce Approximately 2200 units for all products being recalled
Distribution Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.
 
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