Z-1076-2017 Class II Terminated
FDA device recall Z-1076-2017 was initiated by INO Therapeutics (dba Ikaria) on November 21, 2016 and is designated Class II. Reason for recall: Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device. The recall status is terminated (terminated December 20, 2017). Affected quantity: 45.
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- November 21, 2016
- Termination Date
- December 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45
Product Description
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
Reason for Recall
Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.
Distribution Pattern
US Distribution to the states of : CA, CO, DC, FL, GA, HI, IA, IL, IN, MI, MN, NC, NJ, NM, NY, OH, PA, and TX
Code Information
Serial Numbers: DS20070030, DS20070043, DS20070094, DS20070268, DS20090096, DS20090458, DS20090484, DS20090539, DS20090620, DS20090645, DS20100071, DS20100118, DS20100216, DS20100266, DS20100268, DS20100330, DS20100439, DS20100496, DS20100604, DS20100675, DS20100744, DS20100762, DS20100950, DS20101199, DS20101337, DS20101359, DS20101369, DS20101406, DS20101443, DS20101524, DS20110242, DS20110480, DS20110577, DS20110849, DS20110868, DS20110912, DS20110915, DS20110972, DS20110976, DS20110990, DS20120008, DS20120161, DS20120266, DS20120281, DS20120370.