Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.
FDA device recall Z-0900-05 · posted 2005-06-17 · Terminated
Recall details
- Recalling firm
- HK Surgical Inc
- Reason for recall
- Risk of hubs becoming disconnected from the cannula.
- Action taken
- Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.
- Root cause
- Other
- Status
- Terminated
- Product code
- FIE
- Quantity affected
- 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.
- Date initiated
- 2004-12-03
- Date posted
- 2005-06-17
- Date terminated
- 2012-04-19
- Location
- San Juan Capistrano, CA
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