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U.S. Department of Health and Human Services

Class 2 Device Recall CapsLock Cannula

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  Class 2 Device Recall CapsLock Cannula see related information
Date Initiated by Firm July 12, 2005
Date Posted July 22, 2005
Recall Status1 Terminated 3 on July 24, 2006
Recall Number Z-1043-05
Recall Event ID 32688
Product Classification Cannula, Surgical, General & Plastic Surgery - Product Code GEA
Product ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.
Code Information Lot Numbers: 1905, 1904
Recalling Firm/
ArthroCare Corporation
680 Vaqueros Ave
Sunnyvale CA 94085-3523
Manufacturer Reason
for Recall
Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection
FDA Determined
Cause 2
Action The firm (Arthocare UK) has issued notification letters to all consignees via overnight delivery informing them of the situation.
Quantity in Commerce 500 units, 180 in the U.S., 320 aborad
Distribution The product was distributed to 19 consignees in foreign countries, including Denmark, Spain, Lebanon, Finland, Saudi Arabia, the UK, Egypt, Italy, and Australia, as well as 12 medical facilities in New Jersey, New York, Ohio, Maryland, Montana, Oregon, Illinois, Washington, Wisconsin and Nevada. Dates of distribution and manufacture are approximations, provided by the recalling firm.
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.