Recall Z-1043-05 ยท GEA Cannula, Surgical, General & Plastic Surgery
ArthroCare Corporation
ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.
| Date | Jul 22, 2005 (initiated Jul 12, 2005) |
| Status | Terminated |
| Reason | Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection |
| Root cause | Other |
| Action | The firm (Arthocare UK) has issued notification letters to all consignees via overnight delivery informing them of the situation. |
| Quantity | 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. Da |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.