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.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim."
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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