Z-2208-2023Class II

GEM FLOW COUPLER Monitor, PN 5156-00000-011

Name: Z-2208-2023 GEM FLOW COUPLER Monitor, PN 5156-00000-011
Creator: Baxter Healthcare Corporation
Published: 2023-06-19
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-06-19 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of GEM FLOW COUPLER Monitor, PN 5156-00000-011 on 2023-06-19. FDA classified it as Class II and gives the reason as "An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2208-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-19
Posted: 2023-07-20
Recalling firm: Baxter Healthcare Corporation
Product: GEM FLOW COUPLER Monitor, PN 5156-00000-011
Product code: DPW Flowmeter, Blood, Cardiovascular
Reason for recall: An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.
FDA root cause: Under Investigation by firm
Action: Synovis Micro Companies Alliance (MCA), Inc., a subsidiary of Baxter International Inc., is issuing an Urgent Medical Device Correction to its consignees on 06/19/2023 by USPS First Class Mail. The notice explained the problem with the device, risk, and provided the following method to circumvent the problem: "The affected flow coupler monitors may continue to be used. To avoid encountering this issue, please use the monitor while connected to an AC power supply whenever possible. However, if using battery power, Baxter advises users to select channel A prior to shutting down the monitor. Upon powering the monitor back up, please check to ensure that the channel illuminated via the hardware button matches the LCD screen channel display. If a mismatch occurs, touch the channel display on the LCD screen or press the hardware button for channel B to resolve the issue. For general questions regarding this communication, please contact Synovis MCA at 800-510-3318 or 205-941-0111, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday."
Quantity in commerce: 122 units
Distribution: US
Product codes and lots: GTIN 00844735006148, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2208-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2208-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20

Product code DPW

K191252Class IIGem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc. / cleared 2019-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)