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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