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Z-1959-2013 Class II Terminated

Recalled by Vital Signs Devices, a GE Healthcare Company — Totowa, NJ

Recall Details

Product Type: Devices
Report Date: August 21, 2013
Initiation Date: July 18, 2013
Termination Date: January 2, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12,239 units (5,002 units US, 7,237 units OUS).

Product Description

Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.

Reason for Recall

GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe

Distribution Pattern

Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom.

Code Information

GE product number M1024229