Ventlab Infant Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling 14,602 infant resuscitators due to possible volume leakage through the inlet valve during bag compressions.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a severity score of at least 4 per the rubric.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the Ventlab Rescue Med Infant Resuscitator, product code BVM700, lot number 101638. The recall was initiated because of a possible volume leakage through the inlet valve during compressions of the resuscitator bag.
The affected devices are disposable resuscitators with an optional built-in pressure monitor, intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. The units were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee.
The FDA has classified this recall as Class I. Consumers and healthcare facilities should stop using the affected devices and contact Ventlab Corporation for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Ventlab Corporation
- Hazard
- Affected units
- 14,602
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: BVM700
- Lot #101638.
Distribution
Part of a larger recall action
This product is one of 12 recalled by Ventlab Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Ventlab Corporation
See all →- SevereVentlab Premium Small Adult Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab AirFlow Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07
Same hazard · volume leakage
See all →- SevereVentlab Stat-Check Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
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