The Recall Desk
HighFDA (Devices)·Z-0901-2015·Announced 2015-01-07

Nonin Medical Recalls Regional Oximetry Sensors Due to Signal Loss

Nonin Medical is recalling specific regional oximetry sensors because they may lose signal when used on diaphoretic patients. No injuries or illnesses have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (signal loss) that poses a risk of harm, but the source explicitly states that no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Nonin Medical, Inc. is conducting a recall of certain SenSmart Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensors (Models 8003CA and 8004CA) and associated materials, including the INT-100 cable, operator's manual, and Quick Start Guide. The affected sensors are single-packed in pouches and multi-packed 20 per shelf-box.

The recall is being conducted because the company received reports of signal loss during the use of short-cabled regional oximetry sensors with diaphoretic patients. The source text explicitly states that no injury or illness has been reported in connection with this issue.

The recall involves 5,892 units, with 5,452 distributed in the US and 440 outside the US. Specific distribution details are to be provided later. Consumers and healthcare providers should stop using the affected sensors and contact Nonin Medical for instructions on replacement or refund.

The recalled product

Product
SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed i
Manufacturer
Nonin Medical, Inc
Category
Medical Device — Oximetry Sensors
Hazard

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 (20)

  • INT100 25605 8825001 PKG ASSY
  • INT100 414312 8825001 PKG ASSY
  • INT100 414353 8825001 PKG ASSY
  • INT100 414405 8825001 PKG ASSY
  • INT100 418061 9705001 PKG ASSY
  • 8004CA
  • 20PK 37245 9705001 PKG ASSY
  • 20PK 36349 9705001 PKG ASSY
  • 20PK 36475 9705001 PKG ASSY
  • 20PK 36476 9705001 PKG ASSY
  • 20PK 36477 9705001 PKG ASSY
  • 20PK 36593 9705001 PKG ASSY
  • 20PK 36693 9705001 PKG ASSY
  • 20PK 36694 9705001 PKG ASSY
  • 20PK 36695 9705001 PKG ASSY
  • 20PK 36696 9705001 PKG ASSY
  • 20PK 36697 9705001 PKG ASSY
  • 20PK 36698 9705001 PKG ASSY
  • 20PK 36886 9705001 PKG ASSY
  • 20PK 36887 9705001 PKG ASSY

Distribution

Distribution scope not specified by the agency.

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