FDA Medical Device Recalls (openFDA)
HK Surgical Inc: Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.
- Recall number
- Z-0900-05
- Recalling firm
- HK Surgical Inc
- Product
- Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.
- Status
- Terminated
- Initiated
- 2004-12-03
- Posted
- 2005-06-17
- Terminated
- 2012-04-19
- Reason
- Risk of hubs becoming disconnected from the cannula.
- Root cause
- Other
- Action
- Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.
- Quantity
- 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.
- Lot, serial or model codes
- All Codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FIE
- Firm FEI
- 1000125732
- Firm city
- San Juan Capistrano
- 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