Date Initiated by Firm |
November 21, 2006 |
Date Posted |
February 15, 2007 |
Recall Status1 |
Terminated 3 on April 13, 2012 |
Recall Number |
Z-0505-2007 |
Recall Event ID |
36866 |
510(K)Number |
K041695 K052585
|
Product Classification |
biopsy plate - Product Code LNH
|
Product |
LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 Channel Breast Biopsy Lateral Grids (pack of 5 grids) or 2) the plate is purchased in pairs with the following part numbers: M3087JG, which contains Liberty 9000 8-Channel Breast Coil, 2 plates and a manual; G3087JH, which contains 2 plates and a manual; M3335LA, which contains a 3T HD 8 channel Vibrant Breast Array, 2 plates and a manual. |
Code Information |
''LOT 6318910'', expiration date 09/2007. |
Recalling Firm/ Manufacturer |
USA Instruments Incorporated 1515 Danner Dr Aurora OH 44202-9273
|
For Additional Information Contact |
Robert B. Smith 800-582-2145
|
Manufacturer Reason for Recall |
The packaging used for the Breast Biopsy Plate may exhibit small holes or tears.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were notifed by certified letter, dated 11/28/06. |
Quantity in Commerce |
250 units |
Distribution |
Nationwide. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = USA INSTRUMENTS, INC.
|