Recall Z-0372-2012
Cincinnati Sub-Zero Products Inc · initiated September 26, 2011
Product
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.
Codes / lots: The following lot codes are subject to recall: 12998, 12999, 19257, 19257A, 19644, 21536, 21537, 27446, 29112, 31081, 31082, 32209, 37281, 38522, 8996, D414723, D416607, D420120, D421702, D423801, D423908, D525212, D515408, D516607, D517108, D520709, D524107, D525502, D527632, D530518, D624011, D624012, D634834 D706611, D709119, D720450, D721118, D722015, and D727416.
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0372-2012
- Initiated
- September 26, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- August 13, 2013
- Product code
- BZT – Stethoscope, Esophageal, With Electrical Conductors
- Quantity
- 369,680
- Distribution
- Nationwide distribution and Canada.
- Recalling firm
- Cincinnati Sub-Zero Products Inc, Cincinnati, OH