Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery recall
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a…
Why was Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a…
- Recalling firm
- INO Therapeutics (dba Ikaria)
- Quantity
- 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
- Recall date
- February 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)