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U.S. Department of Health and Human Services

Class 2 Device Recall Continuous flush device

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 Class 2 Device Recall Continuous flush devicesee related information
Date Initiated by FirmJuly 01, 2005
Date PostedOctober 21, 2005
Recall Status1 Terminated 3 on August 09, 2011
Recall NumberZ-0071-06
Recall Event ID 33316
510(K)NumberK791844 
Product Classification Catheter, Continuous Flush - Product Code KRA
ProductTAKHPQ60R continuous flow catheter.
Code Information Part Number 682117. Lot numbers 107612, 109012, 110019, 112035, 210060, 212386, 301150.
FEI Number 1710034
Recalling Firm/
Manufacturer		 Becton Dickinson Medical Systems
9450 S State St
Sandy UT 84070-3213
For Additional Information Contact
801-565-2341
Manufacturer Reason
for Recall		Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Quantity in Commerce550 units
DistributionNationwide, including PR. VA facilities in OH, WA, NV and NY. No military or foreign distribution by US firm..
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 = KRA
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