Z-0898-05

Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8...

Name: Z-0898-05 Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8...
Creator: HK Surgical Inc
Published: 2004-12-03
License: https://open.fda.gov/license/

HK Surgical Inc / initiated 2004-12-03 / Terminated

FDA source

HK Surgical Inc began a recall of Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6 on 2004-12-03. The reason FDA records is "Risk of hubs becoming disconnected from the cannula". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0898-05
Status: Terminated
Initiated: 2004-12-03
Posted: 2005-06-17
Terminated: 2012-04-19
Recalling firm: HK Surgical Inc
Product: Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6
Product code: FIE Needle, Fistula
Reason for recall: Risk of hubs becoming disconnected from the cannula.
FDA root cause: Other
Action: Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.
Quantity in commerce: To be determined
Distribution: Nationwide, Saudi Arabia, New Zealand, Phillipines, Switzerland, Canada, Netherlands, Taiwan, Germany, Japan, Malaysia, United Kingdom, Indonesia, Austria, Belgium, Puerto Rico, England.
Product codes and lots: All codes.

Product code FIE

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)