Welch Allyn Connex Spot Monitor recallZ-2581-2023 · Baxter Healthcare Corporation · initiated Aug 10, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
FDA root cause category: Device Design
What the company is doing
The consignee recall notification was sent out via email 08/10/2023. The letter instructs the consignee to immediately locate, isolate, and cease all use of the affected product, contact Baxter Customer Service and Technical Support to arrange for return and replacement of the impacted units, acknowledge receipt by responding on the customer portal, and notify other affected customers of the consignee. Affected product will be removed from the field and customers will receive replacement units of the Connex Spot Monitor. Impacted product will be returned to Baxter and will be destroyed per the Return Material Authorization process.
Recall details
- Recall number
- Z-2581-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2023
- Posted by the FDA
- Sep 12, 2023
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 2 units
- Product code
- MWI
- FDA submissions
- K142356
- Distribution
- US Nationwide distribution in the state of CA.
Product description
Welch Allyn Connex Spot Monitor
Code information (models, lots, serial numbers)
Product Code: 75MT-B; UDI: 00732094209372; Serial Numbers: 100027582923 and 100027862923
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
Other devices under the same FDA submission
5 devices cleared under K142356 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Welch Allyn, Inc. 901001Welch Allyn, Inc. · Monitor, physiological, patient (without arrhythmia detection or alarms)1 recall5 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)1 recall1 report
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · Monitor, physiological, patient (without arrhythmia detection or alarms)1 recall0 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · Monitor, physiological, patient (without arrhythmia detection or alarms)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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