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U.S. Department of Health and Human Services

Class 2 Device Recall Adelante

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  Class 2 Device Recall Adelante see related information
Date Initiated by Firm July 03, 2008
Date Posted October 29, 2008
Recall Status1 Terminated 3 on December 09, 2008
Recall Number Z-0130-2009
Recall Event ID 49558
510(K)Number K073100  
Product Classification introducer set - 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 FL 34683
For Additional Information Contact
727-937-2511 Ext. 133
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		 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 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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