FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Welch Allyn Connex Spot Monitor
- Recall number
- Z-2581-2023
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Welch Allyn Connex Spot Monitor
- Status
- Open, Classified
- Initiated
- 2023-08-10
- Posted
- 2023-09-12
- Terminated
- not on file
- Reason
- Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
- Root cause
- Device Design
- 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.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of CA.
- Lot, serial or model codes
- Product Code: 75MT-B; UDI: 00732094209372; Serial Numbers: 100027582923 and 100027862923
- 510(k) numbers
- ["K142356"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28