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Class 2 Device Recall General Purpose Temperature Probe |
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Date Initiated by Firm |
July 18, 2013 |
Date Posted |
August 13, 2013 |
Recall Status1 |
Terminated 3 on January 02, 2014 |
Recall Number |
Z-1959-2013 |
Recall Event ID |
65857 |
510(K)Number |
K051873
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Product Classification |
Thermometer, electronic, clinical - Product Code FLL
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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. |
Code Information |
GE product number M1024229 |
Recalling Firm/ Manufacturer |
Vital Signs Devices, a GE Healthcare Company 20 Campus Rd Totowa NJ 07512-1210
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For Additional Information Contact |
800-588-7044
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Manufacturer 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
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FDA Determined Cause 2 |
Use error |
Action |
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. |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FLL and Original Applicant = GE HEALTHCARE
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