Recall Z-0991-2020
Cardinal Health 200, LLC · initiated October 28, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
Codes / lots: All product manufactured after December 4, 2017; Serial Numbers greater than or equal to N17700101
Reason for recall
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.
FDA-determined cause: Under Investigation by firm
Action taken
Cardinal Health issued Correction Notice and Acknowledgement Form via overnight on October 28, 2019 to the direct consignees. The Medical Device Correction Notice provides instructions to our direct consignees to notify any customers who they may have further distributed affected product as to the market action. Letter states reason for recall, health risk and action to take: Customers are instructed that if they have access to a Genius Checker/Calibrator to calibrate all affected Genius thermometers. Following calibration, customers are to contact Cardinal Health Service & Repair to schedule and arrange for the software update on their Genius Checker/Calibrator. Once the updated Genius Checker/Calibrator has been returned to your facility, recalibrate all thermometers. If a customer does not have access to a Genius Checker/Calibrator, they are instructed to contact Cardinal Health Service & Repair to schedule and arrange for their thermometer(s) to be sent to a service center. Contact Cardinal Health Service & Repair to schedule and arrange for your thermometer(s) to be sent to one of our service centers. Monday Friday between 8:00am - 8:00pm EST Service and Repair Line 877-227-3462, Option 1
Details
- Recall number
- Z-0991-2020
- Initiated
- October 28, 2019
- Terminated
- May 17, 2022
- Product code
- FLL – Continuous Measurement Thermometer
- Quantity
- 7425 US; OUS 214278
- Distribution
- Worldwide Distribution - US Nationwide and Foreign in the countries of: Australia Austria Belgium Canada Canary Islands Chile Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana French Polynesia Gabon Germany Gibraltar Greece Guadeloupe Hong Kong Iran, Islamic Republic Of Ireland Israel Italy Kuwait Liechtenstein Luxembourg Martinique Mayotte Mexico…
- Recalling firm
- Cardinal Health 200, LLC, Mansfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0990-2020 Class II | Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not… | 10/28/2019Terminated |
| Z-0992-2020 Class II | Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not… | 10/28/2019Terminated |
| Z-0993-2020 Class II | Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not… | 10/28/2019Terminated |
| Z-0994-2020 Class II | Genius 2 Tympanic Thermometer Private Label Item Code: 3069The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not… | 10/28/2019Terminated |