Atlas FDA

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

FDA device recall Z-1043-05 · posted 2005-07-22 · Terminated

Recall details

Recalling firm
ArthroCare Corporation
Reason for recall
Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection
Action taken
The firm (Arthocare UK) has issued notification letters to all consignees via overnight delivery informing them of the situation.
Root cause
Other
Status
Terminated
Product code
GEA
Quantity affected
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 Ne
Date initiated
2005-07-12
Date posted
2005-07-22
Date terminated
2006-07-24
Location
Sunnyvale, CA

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