Vyaire Medical: 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.

Agency Publication Date: May 10, 2018

Affected Products

Product: AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8004C2. Lot: 1022612

Lot Numbers:

1022612

Product: AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8004C2M, Lot: 0001022613

Lot Numbers:

0001022613

Product: AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8004F, Lots: 0000924948, 0000934061, 0000953218, 0000960729, 0000991584, 0001018701, 0001025673

Product: AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8004M, Lot: 0001025673

Lot Numbers:

0001025673

Product: AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

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, 40inch oxygen reservoir tubing, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8005F, Lot: 0001022611

Lot Numbers:

0001022611

Product: AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8008, Lots: 00010002841, 0001006156, 0001006158, 0001009054, 0001015412, 0001015413, 0001018698, 0001018699, 0001025674, 0001030572

Product: AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8008F. Lot: 0001009055

Lot Numbers:

0001009055

Product: AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8010M. Lots: 0001013508, 0001035875, 0001070565, 0001080150

Product: AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8008C2. Lot: 0001002929

Lot Numbers:

0001002929

Product: AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8008C2M. Lots: 0001022614, 0001035872

Product: AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8010. Lot: 0001007295, 0001015414, 0001018697, 0001022519, 0001022518, 0001034530, 0001040652, 0001040653, 0001043846, 0001043847, 0001044102, 0001064454, 0001067498

Lot Numbers:

0001007295

Product: AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8010BR. Lots: 0000890355, 0000890357, 0000890358, 0000940369, 0000994501, 0001061390, 0001064441, 0001092070

Product: AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8010C2M. Lot: 0001015416

Lot Numbers:

0001015416

Product: AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8017. Lots: 0001022516, 0001025656, 0001025655, 0001029028, 0001040668

Product: AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8018. Lots: 0001006155, 0001013509, 0001013510, 0001019430, 0001025675

Product: AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8019. Lots: 0001006159, 0001010401, 0001034518, 0001034519, 0001040641, 0001040642

Product: AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8020. Lots: 0001002842, 0001018800, 0001018801

Product: AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8021. Lots: 0001010402, 0001022520, 0001018798, 0001054821, 0001058109, 0001064428, 0001073364, 0001075035, 0001082390

Product: AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8032. Lots: 0000911374, 0000917042, 0000921479, 0000924302, 0000929950, 0000933592, 0000944381, 0000949465, 0000963263, 0000966513, 0000966514, 0000969802

Product: AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8035. Lots: 001022606, 0001034508, 0001034509

Product: AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8035C2. Lots: 0001022607, 0001029750, 0001034507

Product: AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8035M. Lot: 0001022617

Lot Numbers:

0001022617

Product: AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8036. Lots: 0001022608, 0001022609, 0001025672

Product: AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8037. Lots: 0001002934, 0001007292

Product: AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8038. Lots: 0001018799, 0001058107, 0001085043

Product: AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8039. Lots: 0001002932, 0001018700

Product: AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8039M. Lots: 0001000959, 0001002931, 0001007291, 0001016628, 0001019907

Product: AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8080BR. Lots: 0000890354, 0000890352, 0000940373, 0000979974, 0000994500

Product: AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 7730ALS. Lots: 0000993426, 0000994766, 0000996685, 0001011762, 0001011763, 0001017478, 0001026192, 0001026868, 0001028306, 0001031760, 0001032932, 0001048406, 0001082823

Part Number: 7730IALS. Lots: 0000996572, 0001011800, 0001082819

Product: AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 7730POCH. Lots: 0000993427, 0001069517

Product: AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8038M. Lots: 0001045566, 0001074625, 0001080151, 0001083196, 0001086176

Product: AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Part Number: 2K8040. Lot: 0001073367

Lot Numbers:

0001073367

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78412

Status: Resolved

Manufacturer: Vyaire Medical

Manufactured In: United States

Units Affected: 34 products (24 units; 18 units; 1,260 units; 30 units; 305,136 units; 54 units; 8,058 units; 24 units; 180 units; 24 units; 42 units; 8,124 units; 4,640 units; 6 units; 8,100 units; 2,340 units; 2,262 units; 1,800 units; 3,600 units; 17,172 units; 3.600 units; 2,982 units; 180 units; 4,500 units; 720 units; 900 units; 498 units; 270 units; 1,140 units; 797 units; 20 units; 150 units; 198 units; 180 units)

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Affected Products