Ventlab Manual Resuscitator Bags Recalled Due to Valve Defect
Ventlab LLC is recalling 251,384 manual resuscitator bags because a defective pop-off valve may prevent air delivery during emergency resuscitation.
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 life-support medical device where a mechanical failure could prevent air delivery, posing a significant risk of harm, although the source text does not report specific injuries or illnesses.
Plain-English summary
Ventlab LLC is recalling 251,384 units of its Manual Resuscitator Bag Series, including models such as AF1000, BT2000, and VN2000. These devices are emergency manual resuscitators intended for the pediatric population. The recall covers specific lot numbers ranging from 99523 to 200492.
The recall is due to a defect in the pop-off valve, which may remain open. If the valve stays open, squeezing the bag may not generate enough force to open the duck bill valve, resulting in no air being delivered to the patient. This failure could prevent effective resuscitation in an emergency.
The affected devices were distributed nationwide in Ohio, New York, Texas, Tennessee, Florida, Connecticut, and Virginia. Consumers and healthcare facilities should stop using the affected devices and contact Ventlab LLC for instructions on return or replacement.
The recalled product
- Product
- Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002.
- Manufacturer
- Ventlab LLC
- Affected units
- 251,384
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 (20)
- Manual Resuscitator Bag Series: AF1000
- AF2000
- AF5000
- BT4000
- VN2000
- VN5000
- VT1000
- Lot #s105147 -107609. AF1000
- AF3000
- AF4000
- BT2000
- BT3000
- PRO-1900
- SC7000
- SC8120
- SS3200
- VN3000
- VN4000
- Lot #s 106245 -107291. VN2102
- Lot #200349. AF1000
Distribution
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