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U.S. Department of Health and Human Services

Class 2 Device Recall Oscor introducer Kit

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  Class 2 Device Recall Oscor introducer Kit see related information
Date Initiated by Firm June 13, 2005
Date Posted August 30, 2005
Recall Status1 Terminated 3 on January 05, 2007
Recall Number Z-1443-05
Recall Event ID 32395
510(K)Number K831751  
Product Classification Introducer, Catheter - Product Code DYB
Product Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc syringe. Sterile EO. Manufacturer Oscor Inc. 3816 DeSoto Boulevard, Palm Harbor, FL 34683. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Models 6089, 6091, 6092, 6093, 6094, 6663 and 6664.
Code Information model 6089 lot numbers: C4-03103 thru C4-03707.  model 6091 lot numbers: C4-03601 thru C4-03691.  model 6092 lot numbers: C4-03110 thru C4-03684.  model 6093 lot numbers: C4-03136 thru C4-03607.  model 6094 lot numbers: C4-03501 thru C4-03610.  model 6663 lot numbers: C4-03055 thru C4-03741.  model 6663 lot numbers: C4-03280 thru C4-03445.
Recalling Firm/
Manufacturer
Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact Guidant Technical Services
800-227-3422
Manufacturer Reason
for Recall
A manufacturer of Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
FDA Determined
Cause 2
Other
Action By Telephone, 6/13/2005. Guidant Sales Reps are to visit hospitals to remove any remaining inventory. Dear Hospital Administrator letter may be left with hospital to explain the removal of product.
Quantity in Commerce 19, 815
Distribution nationwide and worldwide.
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 = DYB and Original Applicant = Oscor Inc.
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