Recalls / —

—#202793

Product

Welch Allyn Connex Spot Monitor

FDA product code

MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K142356

Affected lot / code info

Product Code: 75MT-B; UDI: 00732094209372; Serial Numbers: 100027582923 and 100027862923

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

US Nationwide distribution in the state of CA.

Timeline

Recall initiated

2023-08-10

Posted by FDA

2023-09-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.