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U.S. Department of Health and Human Services

Class 2 Device Recall Outback Percutaneous catheter

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 Class 2 Device Recall Outback Percutaneous cathetersee related information
Date Initiated by FirmMay 18, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 26, 2004
Recall NumberZ-0995-04
Recall Event ID 29212
510(K)NumberK032298 
Product Classification Catheter, Percutaneous - Product Code DQY
ProductLuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
Code Information Model number OTB 1235, Dates of manufacture 11-2003, 03-2004 and 04-2004. Model number OTB 1245, Dates of manufacture 11-2003. 510(k) K032298.
Recalling Firm/
Manufacturer		 Lumend Inc
400 Chesapeake Dr
Redwood City CA 94063-4739
For Additional Information ContactJim Laurin
650-817-8229
Manufacturer Reason
for Recall		Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.
FDA Determined
Cause 2		Other
ActionArea Sales managers were contacted via phone conference on 05/18/04 and instructed to quarantine all outback catheters in their possession and notify all customers with any outback inventory to quarantine the product and make arrangements to retrieve the product from them.
Quantity in CommerceQuantity distributed = 122 catheters.
DistributionSent mainly to Area sales representatives.
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 = DQY
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