Recall Z-1836-2020
Radiometer Medical ApS · initiated March 6, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Codes / lots: Serial Numbers: 902-754R2692N002 and 902-754R2692N001
Reason for recall
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
FDA-determined cause: Component design/selection
Action taken
On 3/5/2020 a "Urgent: Medical device Recall" letter was hand delivered to effective consignees. In addition to providing information on the recall products, the customer notification as consignees to take the following actions: Solution provided by Radiometer: 1. Your Radiometer representative will exchange the power supply of your ABL800 analyzer at the earliest convenience. Your Actions: 1. Cease using the affected ABL800 analyzer and put it on quarantine. 2. Shut down the affected ABL800 analyzer and disconnect the power cord. 3. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative 4. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST.
Details
- Recall number
- Z-1836-2020
- Initiated
- March 6, 2020
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Quantity
- 2 units
- Distribution
- US: in the state of California
- Recalling firm
- Radiometer Medical ApS, Bronshoj