The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2581-2023·Announced 2023-09-20

Welch Allyn Connex Spot Monitor Recalled for Improper Copper Tape Placement

Baxter Healthcare is recalling the Welch Allyn Connex Spot Monitor due to improper placement of copper tape on the back of the liquid-crystal display. The device was distributed in California.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The hazard—improper copper tape placement—is a manufacturing defect without explicit statement of potential harm. Per the rubric, recalls with no injuries reported and theoretical hazards are classified as Moderate or lower.

Plain-English summary

Baxter Healthcare Corporation is recalling the Welch Allyn Connex Spot Monitor, a vital signs monitoring device. The recall affects two units with Product Code 75MT-B and serial numbers 100027582923 and 100027862923, identified by UDI 00732094209372.

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

The recalled units were distributed in California.

The recalled product

Product
Welch Allyn Connex Spot Monitor
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Baxter Healthcare Corporation

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