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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78412

35 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 27, 2017
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Vyaire Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

35 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 35

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag 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.

Z-1547-2018
Recall number
Z-1547-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
5,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8004. Lots: 0001019429, 0001022522, 0001022523

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 2 of 35

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.

Z-1548-2018
Recall number
Z-1548-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8004C2. Lot: 1022612

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 3 of 35

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.

Z-1549-2018
Recall number
Z-1549-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8004C2M, Lot: 0001022613

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 4 of 35

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.

Z-1550-2018
Recall number
Z-1550-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
1,260 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 5 of 35

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.

Z-1551-2018
Recall number
Z-1551-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8004M, Lot: 0001025673

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 6 of 35

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.

Z-1552-2018
Recall number
Z-1552-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
305,136 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 7 of 35

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.

Z-1553-2018
Recall number
Z-1553-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
54 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8005F, Lot: 0001022611

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 8 of 35

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.

Z-1554-2018
Recall number
Z-1554-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
8,058 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 9 of 35

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.

Z-1555-2018
Recall number
Z-1555-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8008F. Lot: 0001009055

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 10 of 35

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.

Z-1556-2018
Recall number
Z-1556-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 11 of 35

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.

Z-1557-2018
Recall number
Z-1557-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8008C2. Lot: 0001002929

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 12 of 35

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.

Z-1558-2018
Recall number
Z-1558-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
42 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8008C2M. Lots: 0001022614, 0001035872

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 13 of 35

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.

Z-1559-2018
Recall number
Z-1559-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
8,124 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 14 of 35

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.

Z-1560-2018
Recall number
Z-1560-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
4,640 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 15 of 35

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.

Z-1561-2018
Recall number
Z-1561-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8010C2M. Lot: 0001015416

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 16 of 35

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.

Z-1562-2018
Recall number
Z-1562-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
8,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 17 of 35

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.

Z-1563-2018
Recall number
Z-1563-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
2,340 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 18 of 35

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.

Z-1564-2018
Recall number
Z-1564-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
2,262 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 19 of 35

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.

Z-1565-2018
Recall number
Z-1565-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
1,800 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 20 of 35

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.

Z-1566-2018
Recall number
Z-1566-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
3,600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 21 of 35

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.

Z-1567-2018
Recall number
Z-1567-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
17,172 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 22 of 35

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.

Z-1568-2018
Recall number
Z-1568-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
3.600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 23 of 35

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.

Z-1569-2018
Recall number
Z-1569-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
2,982 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 24 of 35

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.

Z-1570-2018
Recall number
Z-1570-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8035M. Lot: 0001022617

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 25 of 35

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.

Z-1571-2018
Recall number
Z-1571-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
4,500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 26 of 35

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.

Z-1572-2018
Recall number
Z-1572-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
720 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8037. Lots: 0001002934, 0001007292

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 27 of 35

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.

Z-1573-2018
Recall number
Z-1573-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 28 of 35

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.

Z-1574-2018
Recall number
Z-1574-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
498 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8039. Lots: 0001002932, 0001018700

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 29 of 35

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.

Z-1575-2018
Recall number
Z-1575-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
270 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 30 of 35

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.

Z-1576-2018
Recall number
Z-1576-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
1,140 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 31 of 35

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.

Z-1577-2018
Recall number
Z-1577-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
797 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 32 of 35

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.

Z-1578-2018
Recall number
Z-1578-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 33 of 35

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.

Z-1579-2018
Recall number
Z-1579-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 7730POCH. Lots: 0000993427, 0001069517

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 34 of 35

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.

Z-1580-2018
Recall number
Z-1580-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
198 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

device · product 35 of 35

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.

Z-1581-2018
Recall number
Z-1581-2018
Initiated
April 27, 2017
Classification
Class I
Status
Terminated
Recalling firm
Vyaire Medical
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Part Number: 2K8040. Lot: 0001073367

Distribution pattern

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.