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U.S. Department of Health and Human Services

Class 2 Device Recall AutoSuture

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  Class 2 Device Recall AutoSuture see related information
Date Initiated by Firm May 22, 2006
Date Posted June 17, 2006
Recall Status1 Terminated 3 on December 12, 2007
Recall Number Z-1148-06
Recall Event ID 35491
510(K)Number K902135  
Product Classification venous access system - Product Code FOZ
Product Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit
Catalog Number: 120021
Code Information Lot Numbers: N5M40, N6B01 
Recalling Firm/
United States Surgical
195 McDermott Rd
North Haven CT 06473-3665
For Additional Information Contact Terrence Callahan
Manufacturer Reason
for Recall
The 9F device may contain a 10 F sheath instead of the 9F
FDA Determined
Cause 2
Action United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
Quantity in Commerce 63 UNITS
Distribution Nationwide and International Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec
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 = FOZ and Original Applicant = DEVICE LABS, INC.