Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human pat
FDA device recall Z-1024-2013 · posted 2013-03-29 · Terminated
Recall details
- Recalling firm
- Zyno Medical LLC
- Reason for recall
- Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
- Action taken
- Zyno Medical initiated recall 6/13/11 to accounts advising of a Preventative Maintenance (PM) Schedule and a software upgrade Odometer to monitor counts of accumulative fluid volume infused by the unit. On 3/1/13, firm issued correction notice to users that have not had the software implemented on their unit. Units will be serviced at their scheduled PM. The notice identified the product, problem, and actions to be taken by the customers.
- Root cause
- Process design
- Status
- Terminated
- Product code
- OPP
- Quantity affected
- 2589 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-06-13
- Date posted
- 2013-03-29
- Date terminated
- 2016-07-25
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 (K100705) | Zyno Medical, LLC | 2010-07-08 |
| Z-800 VOLUMETRIC INFUSION PUMP (K071545) | Zyno Medical, LLC | 2007-10-31 |