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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 AutoSuturesee related information
Date Initiated by FirmJune 30, 2005
Date PostedAugust 06, 2005
Recall Status1 Terminated 3 on September 14, 2010
Recall NumberZ-1092-05
Recall Event ID 32569
510(K)NumberK902135 
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
ProductChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 9 French Introducer Kit Catalog Number: 120021
Code Information Lot Numbers: N4G435 N4J328 N4K344 N5A181
Recalling Firm/
Manufacturer
United States Surgical Corporation
195 Mcdermott Rd
North Haven CT 06473-3665
For Additional Information ContactLori Seferian
203-492-8167
Manufacturer Reason
for Recall
The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
FDA Determined
Cause 2
Other
ActionUnited States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.
Quantity in Commerce527 units
DistributionNationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LJS
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