Recall Z-0900-05 ยท FIE Needle, Fistula
HK Surgical Inc
Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.
| Date | Jun 17, 2005 (initiated Dec 3, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.