Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 17, 2006
Date PostedJuly 12, 2006
Recall Status1 Terminated 3 on October 31, 2008
Recall NumberZ-1212-06
Recall Event ID 35506
510(K)NumberK043253 
Product Classification Laparoscope, General & Plastic Surgery, Reprocessed - Product Code NLM
ProductProduct is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
Code Information All lot numbers produced before January, 1, 2006. (Product with expiration date of 12/20008 or earlier.)
FEI Number 1000132435
Recalling Firm/
Manufacturer		 Vanguard Medical Concepts, Inc
5307 Great Oak Dr
Lakeland FL 33815
Manufacturer Reason
for Recall		Review of complaints and testing show that the distal tip of the trocars may separate while in use.
FDA Determined
Cause 2		Package design/selection
ActionThe 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.
Quantity in Commerce13,842
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NLM
-
-