Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #49
FDA device recall Z-0372-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Cincinnati Sub-Zero Products Inc
- Reason for recall
- 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.
- Action taken
- 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. For additional information, customers may contact the Beatrice Washington at 1-800-989-7373 or (513) 772-8810.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BZT
- Quantity affected
- 369,680
- Distribution
- Nationwide distribution and Canada.
- Date initiated
- 2011-09-26
- Date posted
- 2012-01-11
- Date terminated
- 2013-08-13
- Location
- Cincinnati, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (K072621) | Cincinnati Sub-Zero Products, Inc. | 2007-12-13 |