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 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 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: "Possible volume leakage through the inlet valve during compressions of the resuscitator bag."
Plain-English summary
Ventlab Corporation is recalling the Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use. The recall involves 14,602 units distributed nationwide, including Illinois, Ohio, New York, and Tennessee.
The recall was initiated because of possible volume leakage through the inlet valve during compressions of the resuscitator bag. The device is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Healthcare facilities and users should stop using the affected units and contact Ventlab Corporation for instructions on return or replacement. Specific lot numbers and product codes are listed in the official recall documentation.
The recalled product
- Product
- Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, 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…
- 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 (20)
- Product List 071012
- Product Codes: SS3200MB
- Lot #10030
- 100251
- 100381
- 100432
- 100656
- 100791
- 101101
- 10131
- SS3200MB-2
- Lot #100131
- SS3200MB-1
- Lot #101238
- 101370
- 101480
- 101820
- 102009
- SS3200MB-MMC
- Lot #100129
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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See all →- SevereVentlab Premium Small Adult Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab Infant Resuscitator Recalled for Possible Volume Leakage
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- SevereVentlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage
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- SevereVentlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage
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- SevereVentlab AirFlow Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
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