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 in a pouch, then multi-packed, 20 per shelf-box.
Class I - DangerousWhat Should You Do?
- Check if you have this product: PRTNUM_72 PMDES1_01 LOTNUM_72 8825001 PKG ASSY, 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, 8004CA, 20PK 36349 9705001 PKG ASSY, 8004CA, 20PK 36475 9705001 PKG ASSY, 8004CA, 20PK 36476 9705001 PKG ASSY, 8004CA, 20PK 36477 9705001 PKG ASSY, 8004CA, 20PK 36593 9705001 PKG ASSY, 8004CA, 20PK 36693 9705001 PKG ASSY, 8004CA, 20PK 36694 9705001 PKG ASSY, 8004CA, 20PK 36695 9705001 PKG ASSY, 8004CA, 20PK 36696 9705001 PKG ASSY, 8004CA, 20PK 36697 9705001 PKG ASSY, 8004CA, 20PK 36698 9705001 PKG ASSY, 8004CA, 20PK 36886 9705001 PKG ASSY, 8004CA, 20PK 36887 9705001 PKG ASSY, 8004CA, 20PK 36989 9705001 PKG ASSY, 8004CA, 20PK 37066 9705001 PKG ASSY, 8004CA, 20PK 37094 9705001 PKG ASSY, 8004CA, 20PK 37151 9705001 PKG ASSY, 8004CA, 20PK 37245 9705001 PKG ASSY, 8004CA, 20PK 37374 9705001 PKG ASSY, 8004CA, 20PK 37410 9705001 PKG ASSY, 8004CA, 20PK 37514 9705001 PKG ASSY, 8004CA, 20PK 37515 9705001 PKG ASSY, 8004CA, 20PK 37591 9705001 PKG ASSY, 8004CA, 20PK 37607 9705001 PKG ASSY, 8004CA, 20PK 37669 9705001 PKG ASSY, 8004CA, 20PK 37670 9824001 PKG ASSY, 8003CA, 20 PK 36611 9824001 PKG ASSY, 8003CA, 20 PK 36888 9824001 PKG ASSY, 8003CA, 20 PK 36937 9824001 PKG ASSY, 8003CA, 20 PK 37090 9824001 PKG ASSY, 8003CA, 20 PK 37231 9824001 PKG ASSY, 8003CA, 20 PK 37575
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nonin Medical, Inc
- Reason for Recall:
- Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 in a pouch, then multi-packed, 20 per shelf-box.
Product Codes/Lot Numbers:
PRTNUM_72 PMDES1_01 LOTNUM_72 8825001 PKG ASSY, 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, 8004CA, 20PK 36349 9705001 PKG ASSY, 8004CA, 20PK 36475 9705001 PKG ASSY, 8004CA, 20PK 36476 9705001 PKG ASSY, 8004CA, 20PK 36477 9705001 PKG ASSY, 8004CA, 20PK 36593 9705001 PKG ASSY, 8004CA, 20PK 36693 9705001 PKG ASSY, 8004CA, 20PK 36694 9705001 PKG ASSY, 8004CA, 20PK 36695 9705001 PKG ASSY, 8004CA, 20PK 36696 9705001 PKG ASSY, 8004CA, 20PK 36697 9705001 PKG ASSY, 8004CA, 20PK 36698 9705001 PKG ASSY, 8004CA, 20PK 36886 9705001 PKG ASSY, 8004CA, 20PK 36887 9705001 PKG ASSY, 8004CA, 20PK 36989 9705001 PKG ASSY, 8004CA, 20PK 37066 9705001 PKG ASSY, 8004CA, 20PK 37094 9705001 PKG ASSY, 8004CA, 20PK 37151 9705001 PKG ASSY, 8004CA, 20PK 37245 9705001 PKG ASSY, 8004CA, 20PK 37374 9705001 PKG ASSY, 8004CA, 20PK 37410 9705001 PKG ASSY, 8004CA, 20PK 37514 9705001 PKG ASSY, 8004CA, 20PK 37515 9705001 PKG ASSY, 8004CA, 20PK 37591 9705001 PKG ASSY, 8004CA, 20PK 37607 9705001 PKG ASSY, 8004CA, 20PK 37669 9705001 PKG ASSY, 8004CA, 20PK 37670 9824001 PKG ASSY, 8003CA, 20 PK 36611 9824001 PKG ASSY, 8003CA, 20 PK 36888 9824001 PKG ASSY, 8003CA, 20 PK 36937 9824001 PKG ASSY, 8003CA, 20 PK 37090 9824001 PKG ASSY, 8003CA, 20 PK 37231 9824001 PKG ASSY, 8003CA, 20 PK 37575
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0901-2015
Related Recalls
8500M Handheld Pulse Oximeter
Nonin Medical
Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.