FDA Medical Device Recalls (openFDA)
Zyno Medical LLC: Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
- Recall number
- Z-1024-2013
- Recalling firm
- Zyno Medical LLC
- Product
- Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
- Status
- Terminated
- Initiated
- 2011-06-13
- Posted
- 2013-03-29
- Terminated
- 2016-07-25
- Reason
- Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
- Root cause
- Process design
- Action
- 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.
- Quantity
- 2589 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- LOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH
- 510(k) numbers
- ["K071545","K100705"]
- PMA numbers
- not on file
- Product code
- OPP
- Firm FEI
- 3006575795
- Firm city
- Natick
- Firm state
- MA
- 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