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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 June 30, 2005
Date Posted August 06, 2005
Recall Status1 Terminated 3 on September 14, 2010
Recall Number Z-1095-05
Recall Event ID 32569
510(K)Number K902135  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit
Catalog Number: 120045
Code Information Lot Numbers: N4G22 N4G215 N4G436 N4J29 N4J212 N4K218 N4L258 N4M213
Recalling Firm/
Manufacturer
United States Surgical Corporation
195 Mcdermott Rd
North Haven CT 06473-3665
For Additional Information Contact Lori Seferian
203-492-8167
Manufacturer Reason
for Recall
The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
FDA Determined
Cause 2
Other
Action United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.
Quantity in Commerce 2393 units
Distribution Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
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 = LJS and Original Applicant = DEVICE LABS, INC.
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