Device recall: Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human…

Class II FDA enforcement event 64448. Recall start date: 13 Jun 2011. Status in the FDA record: Terminated. Termination date: 25 Jul 2016.

Reason for recall, in the words of FDA

Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Zyno Medical LLC started this device recall on 13 Jun 2011. The firm address in the FDA record is in Natick, MA. FDA put the recall in Class II. FDA event 64448 has 1 product record. The first FDA enforcement report date is 10 Apr 2013. The record gives the status Terminated, with the termination date 25 Jul 2016.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution.

Recalling firm

Zyno Medical LLC, Natick, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 64448: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1024-2013	Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.	2589 units	Class II	Terminated	10 Apr 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2011: 114
Share of these events in Class II: 89%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Zyno Medical LLC
Initiated	Product (first record)	Type	Class	Records
7 May 2025	Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pat	Device	Class I	4
18 Oct 2024	Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to pr	Device	Class II	1
30 Sep 2024	Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is inte	Device	Class III	1
13 Sep 2024	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F	Device	Class I	1
4 Jun 2024	Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps	Device	Class II	1
20 Dec 2023	Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and	Device	Class II	1
29 May 2019	Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gr	Device	Class II	2
29 Jul 2016	Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-8	Device	Class II	4

Zyno Medical LLC: all 9 events

Official channels

FDA enforcement report Z-1024-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 64448. https://recallregister.com/fda/ii/64448/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution.
What quantity of product is in FDA event 64448?: The FDA record gives this quantity: 2589 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2011 have the same class?: 89% of the 114 device events that started in 2011 are in Class II.