Recall Z-0372-2012 ยท BZT Stethoscope, Esophageal, With Electrical Conductors
Cincinnati Sub-Zero Products Inc
Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient's core body temperature.
| Date | Jan 11, 2012 (initiated Sep 26, 2011) |
| Status | Terminated |
| Reason | Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error. |
| Root cause | Nonconforming Material/Component |
| Action | Cincinnati Sub-Zero Products, Inc., issued an "Urgent Medical Device Field Action" letter on November 1, 2011 to all affected customers. The letter includes; description of product and problem, and a list of the affected lot numbers. The letter instructs the customers to discontinue use of the device. All unused product is to be returned to the Biomedical/Clinical Engineering and/or Service Department for an replacement and all used probes are to be disposed of in accordance with hospital policy. The customers are also instructed to complete and return an attached Recall Response Form ASAP. F |
| Quantity | 369,680 |
| Distribution | Nationwide distribution and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072621 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR Cincinnati Sub-Zero Products, Inc., Dec 13, 2007 |