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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 FirmNovember 20, 2003
Date PostedDecember 18, 2003
Recall Status1 Terminated 3 on November 30, 2004
Recall NumberZ-0242-04
Recall Event ID 27871
Product Classification Catheter, Continuous Flush - Product Code KRA
ProductVAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.
Code Information Lot 58151473
FEI Number 3003081151
Recalling Firm/
Manufacturer		 Edwards Lifesciences AG
Parque Industrial Itabo
Km. 18.5 Carr. Sanchez
Haina, San Cristobal Dominican Republic
For Additional Information ContactDana Rodriguez
949-250-2459
Manufacturer Reason
for Recall		Seal integrity, sterility not assured.
FDA Determined
Cause 2		Other
ActionLetter was sent to all customers requesting return of the unused lot on 11/20/2003.
Quantity in Commerce21150
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.
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