SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA...
FDA Recall #Z-0901-2015 — Class II — November 25, 2014
Product 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.
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.
Recalling Firm
Nonin Medical, Inc — Plymouth, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5892 (5452 US, 440 OUS)
Distribution
To be provided later.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.