Exact FDA event identifier

Event 63347

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

Event summary

Timeline bucket: July 11, 2012
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Ventlab Corporation

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

12 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 12

Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0170-2013

Recall number: Z-0170-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product List 071012, Product Codes: SS3200MB, Lot #10030, 100251, 100381, 100432, 100656, 100791, 101101, 10131; SS3200MB-2, Lot #100131; SS3200MB-1, Lot #101238, 101370, 101480, 101820, 102009; SS3200MB-MMC, Lot #100129; SS3200MBP-2, Lot #102057; SS3200MBP-M00, Lot #100132, 101462, 102051; SS3200OB, Lot #100133, 100252, 100979, 101178, 101863, 101975 and SS3200OB-PW, Lot #100134, 100253.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 2 of 12

Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0171-2013

Recall number: Z-0171-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product List 071012, Product Code: PRO-5009P, Lot #102217.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 3 of 12

Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0172-2013

Recall number: Z-0172-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product List 071012, Product Codes: SC9001C, Lot #101360, 101751, 101819, 101948, 102090, 102164 and SC9001C-C, Lot #101100, 101441, 101780, 102193.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 4 of 12

V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0173-2013

Recall number: Z-0173-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product List 071012, Product Codes: VN3200MB, Lot #102032, VN3100MB-2, Lot #102033; VN3100MBP, Lot #102046, 102182; VN3100MB-PW2, Lot 3102050; VN3100OB, Lot #102150.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 5 of 12

Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0174-2013

Recall number: Z-0174-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Code: Product List 071012, Product Codes: BT2200FK, Lot #100196, BT2216, Lot #100138, BT2216F, Lot #100139, BT2216K, Lot #100197, BT2220, Lot #100140, BT2220, Lot #100141, BT2416, Lot #100142, BT2416F, Lot #100143, BT2416K, Lot #100198, BT2420, Lot #100144, BT2420F, Lot #100145 and BT2420FK, Lot #101081.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 6 of 12

AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0175-2013

Recall number: Z-0175-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product List 071012, Product Code: AF1040MB, Lot #102091 and 102191; AF1040MBP, Lot #102106 and 102174; AF1040MBS, Lot #102189, AF1040MB-S5, Lot #102105, AF1040MB-T, Lot #101917 and 102151; AF1100MB, Lot #102227, AF1140MB, Lot #102081 and 102139, AF1140MB-K, Lot #102093 and 102165; AF1140MB-P5, Lot #102145; AF1140MBP-T, Lot #102096 and Product Code: AF1140MB-T, Lot #101666.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 7 of 12

Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0176-2013

Recall number: Z-0176-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product List 071012, Product Codes: PRO-1904, Lot #100155, 100183, 100451, 100497, 100655, 101577 and PRO-1925, Lot #101550, 101604101657.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 8 of 12

Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.

Z-0177-2013

Recall number: Z-0177-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product Code: VN4100OB, Lot #102015.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 9 of 12

Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0178-2013

Recall number: Z-0178-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product Code: VN500MX, Lot #102194.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 10 of 12

Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0179-2013

Recall number: Z-0179-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product Code: BVM700, Lot #101638.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 11 of 12

AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0180-2013

Recall number: Z-0180-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product Code: AF3100MB-M1, Lot #102185; AF3140MB-I, Lot #102129 and AF3140MB-K, Lot #101592, 101729 &102130. Recall was amended to include the following: Product Code: AF3040MB, Lot#101450 &101634; AF3040MB-K, Lot #101728; AF3100MB, Lot #101562, 101687 & 102120; AF3100MB-M01, Lot #102121; AF3100MB-M1, Lot #101285, 102122 & 102185; AF3100MBP, Lot #101264 & 101437; AF3140MB, Lot #101154, 101306, 101661, 102126, 102168; AF310MB-2, Lot #101222 & 102127; AF3140MB-D1, Lot #101223, 101303, 101386 &102128; AF3140MB-D12I, Lot #101368; AF3140MB-I, Lot #101451; AF3140MB-M1, Lot #101730; AF3140MB-P, Lot #101266, 101366, 101614 & 102132 and AF3140OB, Lot #101156 &102134.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.

device · product 12 of 12

AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Z-0181-2013

Recall number: Z-0181-2013
Initiated: July 11, 2012
Classification: Class I
Status: Terminated
Recalling firm: Ventlab Corporation
Quantity: 14,602 total for all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Code information

Product Code: AF5140MBPWTD5, Lot #101806 and 102163; AF5140MB-T, Lot #102075 and AFD5140MB-T, Lot #101928 &102211. Recall was amended to include the following: AF5140MBS-I, Lot #101898; AF5140MB-ST, Lot #101896; AF5140MBS, Lot #101900 and AF5140MBS-R, Lot #101899.

Distribution pattern

Nationwide Distribution including IL, OH, NY and TN.