AirLife Resuscitation recall
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation…
Why was AirLife Resuscitation recalled?
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
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?
Part Number: 2K8005, Lots: 0000908575, 0000909893, 0000909894, 0000911377, 0000911378, 0000911379, 0000913867, 0000912890, 0000913868, 0000915438, 0000915439, 0000915440, 0000915441, 0000915442, 0000915443, 0000917043, 0000917045, 0000917047, 0000917049, 0000917051, 0000921480, 0000921482, 0000921484, 0000921485, 0000921493, 0000921494, 0000921495, 0000921497, 0000921498, 0000924307, 0000924308, 0000924309, 0000924955, 0000924310, 0000924953, 0000924954, 0000927816, 0000927818, 0000927819, 0000927821, 0000928093, 0000928092, 0000931291, 0000931292, 0000931298, 0000931299, 0000933583, 0000933584, 0000934282, 0000934283, 0000934294, 0000934295, 0000934297, 0000934284, 0000936070, 0000936423, 0000939901, 0000939902, 0000939903, 0000939904, 0000944392, 0000944394, 000094395, 0000944398, 0000947493, 0000947495, 0000947496, 0000947498, 0000949446, 0000949447, 0000949448, 0000949459, 0000949460, 0000949461, 0000953220, 0000953221, 0000953222, 0000953229, 0000956649, 0000956650, 0000956671, 0000956673, 0000956674, 0000960227, 0000960228, 0000960230, 0000960721, 0000960833, 0000960723, 0000963256, 0000963258, 0000963259, 0000966515, 0000966516, 0000967268, 0000967269, 0000969798, 0000969799, 0000970277, 0000970278, 0000972936, 0000972938, 0000973459, 0000975503, 0000978637, 0000978639, 0000979969, 0000979970, 0000979971, 0000981789, 0000981792, 0000982835, 0000983469, 0000983470, 0000985673, 000098743, 0000988744, 0000988751, 0000988752, 0000988753, 0000989200, 0000991579, 0000991581, 0000992071, 0000992073, 0000994613, 0000994614, 0000994615, 0000997892, 0000997893, 0000998781, 0001000349, 0001000494, 0001000350, 0001000352, 0001002279, 0001002280, 0001000493, 0001002018, 0001000495, 0001006129, 0001006132, 0001007297, 0001009051, 0001009052, 0001010334, 0001010335, 0001011052, 0001011053, 0001012634, 0001013504, 0001013505, 0001014036, 0001014037, 0001016489, 0001018910, 0001018703, 0001022525, 0001022604, 0001025652, 0001025653, 0001025654, 0001027221, 0001027222, 0001027223, 0001029211, 0001029212, 0001030580, 0001030581, 0001030582
- Product
- AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation…
- Recalling firm
- Vyaire Medical
- Quantity
- 305,136 units
- Distribution
- Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
- Recall date
- May 16, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)