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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 12, 2003
Date PostedJune 12, 2003
Recall Status1 Terminated 3 on October 14, 2003
Recall NumberZ-0925-03
Recall Event ID 26365
510(K)NumberK980992 
Product Classification Set, Administration, Intravascular - Product Code FPA
ProductStatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
Code Information Lot D207201
FEI Number 1000117366
Recalling Firm/
Manufacturer		 Venetec Intl Inc
12555 High Bluff Dr Ste 170
San Diego CA 92130
For Additional Information ContactAlbert M. Misajon
858-350-7899
Manufacturer Reason
for Recall		Set tubing disconnected from the male luer lock during use on patients. Misassembled.
FDA Determined
Cause 2		Other
ActionA recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product.
Quantity in Commerce3150 units
DistributionOne distributor sent the product to 6 hospitals in the states of CT, IN, PA, TN.
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 = FPA
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