Reported Apr 10, 2013 · Terminated
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human…
Zyno Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zyno Medical LLC · 10 Tech Circle · Natick, MA · 01760
Is this the product you have?
- Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
- Lot codes and dates
LOT # 20080416-zs520080711-zs520080826-zs520081022-zs520090126-zs5 20090320-zs520090507-zs520090612-zs520090706-zs520090910-zs5 20091110-zs520100106-C20100420-D2010072920101005-BJ 20100910-SH20101013-SH20101206-SH20110110-SH20110111-SH 20110204-SH20110210-SH20110308-SH20110505-SH
- Amount recalled
- 2589 units
Where it was sold
- Nationwide
Why it was recalled
Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
This product could cause temporary or reversible health problems — stop using it.
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