Recall Z-1959-2013
Vital Signs Devices, a GE Healthcare Company · initiated July 18, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: GE product number M1024229
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
FDA-determined cause: Use error
Action taken
The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 23, 2013 via Fed Ex beginning on July 29, 2013 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE will update the Instructions for Use (IFU) and pouch label with new content related to insertion locations. GE has will also place the probe (M1024229) on quality hold until the new labeling changes are implemented. If you have any questions or concerns regarding this notification, please contact GEMSIT Customer Service at 1-800-588-7044 (Domestic) or Vital Signs Customer Service at 1-800-932-0760 (international). Hours of operation: 8:00 am EST to 6:00 pm EST.
Details
- Recall number
- Z-1959-2013
- Initiated
- July 18, 2013
- Posted by FDA
- August 13, 2013
- Terminated
- January 2, 2014
- Product code
- FLL – Continuous Measurement Thermometer
- Quantity
- 12,239 units (5,002 units US, 7,237 units OUS).
- Distribution
- 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.
- Recalling firm
- Vital Signs Devices, a GE Healthcare Company, Totowa, NJ