Z-1043-05

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

Name: Z-1043-05 ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard...
Creator: ArthroCare Corporation
Published: 2005-07-12
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2005-07-12 / Terminated / root cause: packaging

FDA source

ArthroCare Corporation began a recall of ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905 on 2005-07-12. The reason FDA records is "Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1043-05
Status: Terminated
Initiated: 2005-07-12
Posted: 2005-07-22
Terminated: 2006-07-24
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.
Product code: GEA Cannula, Surgical, General & Plastic Surgery
Reason for recall: Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection
Root cause tag: packaging
FDA root cause: Other
Action: The firm (Arthocare UK) has issued notification letters to all consignees via overnight delivery informing them of the situation.
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: 1905, 1904

Product code GEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)