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.
FDA Recall Z-0901-2015 · Posted 2014-12-31
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Recalling FirmNonin Medical, Inc
Recall StatusTerminated
Product CodeDQA
Date Initiated2014-11-25
Date Terminated2015-09-01
Product Quantity5892 (5452 US, 440 OUS)
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.
Firm Action
Consignees were sent a Nonin letter dated November 24, 2014. The letter described the problem and the product affected. They requested consignees to discontinue the use of the products and return it to Nonin. Consignees were asked to complete and return the "Medical Device Market Withdrawal Return Response Form". For questions and additional information they can contact James H. Russell at 763-577-2260 or e-mail [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
To be provided later.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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