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U.S. Department of Health and Human Services

Class 3 Device Recall Katzen (TM) Infusion Wire

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 Class 3 Device Recall Katzen (TM) Infusion Wiresee related information
Date Initiated by FirmDecember 12, 2006
Date PostedMarch 21, 2007
Recall Status1 Terminated 3 on July 20, 2007
Recall NumberZ-0642-2007
Recall Event ID 36979
510(K)NumberK883880 
Product Classification Infusion Wire - Product Code DQX
ProductBoston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for the delivery of agents in either a 'pulse-spray' or 'slow weep' technique. Order No. REF: 46-193 (M001461930).
Code Information Lot/Batch #: 9052739
Recalling Firm/
Manufacturer		 Boston Scientific
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.
FDA Determined
Cause 2		Other
ActionAn Urgent Medical Device Recall letter, dated December 12, 2006 was sent to affected hospitals Risk Manager beginning 12/12/2006. The letter describes the issue and product affected, requests that further distribution or use of any remaining product cease immediately, and provides information for returning product to Boston Scientific Replacement product will be issued for all recalled product returned from affected facilities. A Reply Verification Tracking Form is requested to be completed and returned to Boston Scientific by Wednesday, December 27, 2006.
Quantity in Commerce10 units
DistributionUS only to: FL, GA, IN, NY.
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 = DQX
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