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Open, Classified

Welch Allyn Connex Spot Monitor

FDA Recall Z-2581-2023 · Posted 2023-09-12

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeMWI
Date Initiated2023-08-10
Product Quantity2 units

Reason for Recall

Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the state of CA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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