Date Recall Initiated |
October 19, 2006
|
Date Posted |
February 08, 2007
|
Recall Number |
Z-0414-2007
|
Product |
AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.
|
Code Information |
94724 95261 104057
94853 95272 104217
94893 100062 104335
94894 102389 104337
94897 102394 104343
94953 102681 104584
94957 102851 105517
94962 103100
94964 103103
95024 103200
95026 103288
95029 103293
95069 103297
95135 103566
95259 103570
|
Recalling Firm/ Manufacturer |
Ascent Healthcare Solutions, Inc.
5307 Great Oak Dr
Lakeland
, Florida
33815
|
Reason For Recall |
The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.
|
Action |
The recall was initiated on 10/19/2006 by direct distribution of the recall notice to direct accounts by the firm's sales force. The firm also posted the notification on their web site. All customers were instructed to examine their inventories for the product and to remove and quarantine all affected product. Instructions on returning the product to the firm were also included along with a response form.
|
Quantity in Commerce |
1566
|
Distribution |
Nationwide
|
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