Devices

Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor

Model / Serial
All lots of the CapnoProbe are under recall. Each unit has a code number printed on the packaging.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
The firm has distributed the sensors to 1 researcher in Europe, and 68 to direct customers (medical facilities) and 112 Field Sales Reps. Currently, there are no finished goods at the manufacturing site. 655 cases of product were disposed of at the distribution facility due to product expiration. The firm estimates 442 cases (3,536 units) to be in distribution channels.
Product Description
The probes involved have been part of the Nellcor¿ CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time.
Manufacturer
Nellcor Puritan Bennett
1 Event
- Recall of Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor

Manufacturer

Nellcor Puritan Bennett

Manufacturer Address
Nellcor Puritan Bennett, 4280 Hacienda Dr, Pleasanton CA 94588-2719
Source
USFDA

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