FDA Medical Device Recalls (openFDA)
ArthroCare Corporation: ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.
- Recall number
- Z-1043-05
- Recalling firm
- ArthroCare Corporation
- Product
- ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.
- Status
- Terminated
- Initiated
- 2005-07-12
- Posted
- 2005-07-22
- Terminated
- 2006-07-24
- 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. Dates of distribution and manufacture are approximations, provided by the recalling firm.
- Lot, serial or model codes
- Lot Numbers: 1905, 1904
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEA
- Firm FEI
- 3010813691
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28