Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
FDA Recall Z-1212-06 · Posted 2006-07-12
Recalling FirmVanguard Medical Concepts, Inc
Recall StatusTerminated
Product CodeNLM
Date Initiated2006-03-17
Date Terminated2008-10-31
Product Quantity13,842
Reason for Recall
Review of complaints and testing show that the distal tip of the trocars may separate while in use.
Firm Action
The firm sent recall notification letters to its consignees on 3-17-2006. They were instructed to discontinue use of the 35NLT, 35NST and 35Ol Reprocessed Optiview Trocars with expiration date of 12/20008 or earlier immediately. Any of this product in inventory were to be returned to the manufacturer for credit. The firm also offered the assistance of its representatives in returning all affected profucts. The investigation is ongoing, and corrective actions associated with the root cause of tips breaking off have been identified and are being implemented.
Root Cause
Package design/selection
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.