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U.S. Department of Health and Human Services

Class 1 Device Recall Arstasls One Access System

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 Class 1 Recall
Arstasls One Access System
see related information
Date Posted February 04, 2011
Recall Status1 Terminated on February 16, 2011
Recall Number Z-0993-2011
Recall Event ID 57507
Premarket Notification
510(K) Numbers
K091006  K100615  K102728 
Product Classification Introducer, Catheter - Product Code DYB
Product Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft and (3) Handle with control features. Product is manufactured and distributed by Arstasis Inc., San Carlos, CA The Arstasis One Access System is a sterile, single use system intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is Indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F Introducer sheaths.
Code Information Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334
Recalling Firm/
Manufacturer
Arstasis, Inc
740 Bay Rd
Redwood City, California 94063-2469
For Additional Information Contact Debra Cogan
650-508-1549 Ext. 273
Manufacturer Reason
for Recall
Device has the potential to fracture and sheath separation during use.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, Arstasis, initiated a market withdrawal and sent notification via letters dated October 19, 2010, to customers informing the customers that Arstasis is implementing a product improvement and will replace all existing inventory that the customer has on their shelf with the improved product. The customers were instructed to work closely with their local Arstasis territory manager to ensure that their product replacement is handled satisfactorily, and complete and return the PRODUCT REPLACEMENT and PRODUCT RETURN forms to Arstasis Customer Service via fax at 1-877-688-8417 or email to customerservice@arstasis.com. If you have any questions or concerns, contact Customer Service toll free at 1-877-594-4545.
Quantity in Commerce 330 units
Distribution Worldwide Distribution
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 = ARSTASIS, INC.
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