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U.S. Department of Health and Human Services

Class 2 Device Recall Adelante

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 Class 2 Recall
Adelante
see related information
Date Posted October 29, 2008
Recall Status1 Terminated on December 09, 2008
Recall Number Z-0130-2009
Recall Event ID 49558
Premarket Notification
510(K) Number
K073100 
Product Classification Introducer, Catheter - Product Code DYB
Product Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
Code Information Lot Numbers: C1-02452, C1-02453, C1-02452, C1-02458, C1-02462.
Recalling Firm/
Manufacturer
Oscor, Inc.
3816 Desoto Blvd
Palm Harbor, Florida 34683
Manufacturer Reason
for Recall
Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.
FDA Determined
Cause 2
DESIGN: Process Design
Action Oscor notified the Direct Account by letter on 07/03/2008. Direct account was asked to return all unused Introducers back to Oscor. All returned products should be labeled with the Return Goods Product number.
Quantity in Commerce 396
Distribution Product was distributed to one direct account in MN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Oscor Inc.
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