Recall record at a glance
| Official record | Z-0901-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Nonin Medical, Inc. |
| Report date | Jan 7, 2015 |
| Recall initiation date | Nov 25, 2014 |
| Quantity | 5892 (5452 US, 440 OUS) |
| Location | Plymouth, MN, United States |
Official 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.
Why the product was recalled
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.
Distribution information
To be provided later.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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