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Terminated

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

FDA Recall Z-1043-05 · Posted 2005-07-22

Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeGEA
Date Initiated2005-07-12
Date Terminated2006-07-24
Product Quantity500 units, 180 in the U.S., 320 aborad

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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