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.
FDA Recall Z-0414-2007 · Posted 2007-02-08
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Recalling FirmAscent Healthcare Solutions, Inc.
Recall StatusTerminated
Product CodeNLM
Date Initiated2006-10-19
Date Terminated2008-10-31
Product Quantity1566
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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