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U.S. Department of Health and Human Services

Class 2 Device Recall INOmax DSIR Plus delivery system

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  Class 2 Device Recall INOmax DSIR Plus delivery system see related information
Date Initiated by Firm November 21, 2016
Create Date January 23, 2017
Recall Status1 Terminated 3 on December 20, 2017
Recall Number Z-1076-2017
Recall Event ID 75878
510(K)Number K131686  
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
Product 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.
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.
Recalling Firm/
Manufacturer		 INO Therapeutics (dba Ikaria)
6603 Femrite Dr
Madison WI 53718-6801
For Additional Information Contact Mallinckrodt Customer Care
877-566-9466
Manufacturer 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.
FDA Determined
Cause 2		 Equipment maintenance
Action Recall letter was sent to customers in a e-mail beginning November 21, 2016 with a had copy sent via FedEx overnight with signature receipt beginning December 5, 2016. Devices will be picked up and replaced by Mallinckrodt. Questions can be directed to 1-877-KNOW-INO (1-877-566-9466).
Quantity in Commerce 45
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRN and Original Applicant = INO THERAPEUTICS/IKARIA
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