RecallDepth

ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.

Company
Arthrocare Corporation
Recall Initiated
July 12, 2005
Posted
July 22, 2005
Terminated
July 24, 2006
Recall Number
Z-1043-05
Quantity
500 units, 180 in the U.S., 320 aborad
Firm Location
Sunnyvale, CA

Reason for Recall

Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection

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.

Lot / Code Info

Lot Numbers: 1905, 1904

Root Cause

Other

Action Taken

The firm (Arthocare UK) has issued notification letters to all consignees via overnight delivery informing them of the situation.

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