| | Class 2 Recall
Disposable biopsy plate |  |
| Date Posted |
February 15, 2007 |
| Recall Number |
Z-0518-2007 |
| Product |
The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, 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 and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131. |
| 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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