Ventlab Pro-5000 Adult Resuscitator Recalled for Volume Leakage
Ventlab Corporation is recalling 14,602 Pro-5000 Series Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device intended for life-support during cardiopulmonary arrest. The defect (volume leakage) poses a risk of harm by failing to provide adequate respiratory support, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the Pro-5000 Series Adult Resuscitator, Single Patient Use. These disposable resuscitators are intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. The recall covers units with Product Code PRO-5009P and Lot #102217.
The recall was initiated because of a possible volume leakage through the inlet valve during compressions of the resuscitator bag. This defect could compromise the device's ability to provide adequate respiratory support to patients.
The affected units were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee. Healthcare facilities and users should stop using the affected resuscitators and contact Ventlab Corporation for further instructions or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Ventlab Corporation
- 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 (3)
- Product List 071012
- Product Code: PRO-5009P
- Lot #102217.
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
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