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U.S. Department of Health and Human Services

Class 2 Device Recall Mallincrodt nitric oxide delivery

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 Class 2 Device Recall Mallincrodt nitric oxide deliverysee related information
Date Initiated by FirmJune 23, 2022
Date PostedSeptember 13, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1745-2022
Recall Event ID 90723
510(K)NumberK061901 
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
ProductINOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Mallinckrodt, LLC.
1425 Us Highway 206
Bedminster NJ 07921-2653
For Additional Information ContactMegan Vernak
908-238-6600
Manufacturer Reason
for Recall		The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.
FDA Determined
Cause 2		Under Investigation by firm
ActionMallinkrodt issued via email on 6/23/22 an Urgent Field Safety Notice (FA-R-0023) stating reason for recall, health risk and action to take: Upon receipt of this Field Safety Notice (FSN), INOmax DSIR operators are advised not to use an upgraded Leoni Plus ventilator with the INOmax DSIR. The INOmax DSIR Validated Ventilator List, supplied as Technical Bulletin TB-20005, will be revised to remove the Leoni Plus ventilator and distributed as soon as it is available. A response form is required for this FSN. Please complete the attached form and return as instructed.
Quantity in Commerce4,225 units OUS
DistributionForeign Only: Argentina Australia Austria Beligum Canada Chile Columbia Czech Republic Denmark Ecuador Estonia Finland France Germany Great Britain Hungary Iceland Ireland Italy Latvia Mexico Netherlands Norway Poland Portugal Romania Slovakia South Africa Spain Sweden Switzerland UAE Uruguay
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MRN
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