Welch Allyn Connex Spot Monitor
This recall is currently active, issued September 12, 2023. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- August 10, 2023
- Posted
- September 12, 2023
- Recall Number
- Z-2581-2023
- Quantity
- 2 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
Distribution
US Nationwide distribution in the state of CA.
Lot / Code Info
Product Code: 75MT-B; UDI: 00732094209372; Serial Numbers: 100027582923 and 100027862923
Root Cause
Device Design
Action Taken
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.