Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
Ventlab is recalling Safe Spot Infant Resuscitators due to possible 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 situations (cardiopulmonary arrest) where a functional defect (leakage) poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ventlab Corporation is recalling Safe Spot Infant Resuscitators, Pro-1900 Series, Single Patient Use. The recall involves 14,602 units distributed nationwide, including Illinois, Ohio, New York, and Tennessee. The affected product codes are PRO-1904 and PRO-1925, with specific lot numbers listed in the agency records.
The recall was initiated because of 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 infants experiencing reversible apnea or cardiopulmonary arrest.
Healthcare facilities and consumers who have these specific units should stop using them immediately. Ventlab Corporation is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- 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.
- 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 (10)
- Product List 071012
- Product Codes: PRO-1904
- Lot #100155
- 100183
- 100451
- 100497
- 100655
- 101577 and PRO-1925
- Lot #101550
- 101604101657.
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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