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U.S. Department of Health and Human Services

Class 2 Device Recall Katzen" Infusion Wire

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  Class 2 Device Recall Katzen" Infusion Wire see related information
Date Initiated by Firm August 01, 2011
Date Posted August 23, 2011
Recall Status1 Terminated 3 on August 10, 2012
Recall Number Z-3053-2011
Recall Event ID 59693
510(K)Number K883880  
Product Classification Wire, Guide, Catheter - Product Code DQX
Product Katzen" Infusion Wire, 0.035 in x 180 cm,
UPN Product No. M001461930,
RED Catalog No. 46-193,
Made in USA 8600.
Boston Scientific.
NW 41 Street, Miami, FL 33166.

Intended 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.
Code Information UPN Code: M001461930. Catalog: 46-193. Batch/Lot Description: 14270326.
Recalling Firm/
Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact
Manufacturer Reason
for Recall
Boston Scientific is voluntarily recalling one lot/batch of Katzen" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of 180cm while the actual device length is 145cm.
FDA Determined
Cause 2
Labeling mix-ups
Action Boston Scientific sent an "Urgent Medical Device Recall Removal" letter dated August 1, 2011 to all affected customers. The letter described the problem and product being recalled and advised customers to segregate the affected product immediately and return it to Boston Scientific. Boston Scientific requested the completion and return of the Reply Verification Tracking Form. For additional information on this recall call Boston Scientific Quality Systems at (763) 494-1133.
Quantity in Commerce 33
Distribution (USA) Nationwide distribution including the states of AZ, AR, CA, CO, FL, GA, IL, IN, NV, NY, NC, OH, PA, RI, and TX.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DQX and Original Applicant = MEDI-TECH, INC.