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Vital Signs Devices, a GE Healthcare Company recalls Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthca
Recalled August 21, 2013 · FDA recall Z-1959-2013 · Vital Signs Devices, a GE Healthcare
Hazard
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 · FDA Class II
Units
12,239 units (5,002 units US, 7,237 units OUS).
Sold at
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.
Description
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
Product
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.
Manufacturer(s)
Vital Signs Devices, a GE Healthcare Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →