Ventlab Stat-Check Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling specific lots of Stat-Check Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as Class I recalls involve a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series. The recall covers specific product codes SC9001C and SC9001C-C across multiple lot numbers, including 101360, 101751, 101819, 101948, 102090, 102164, 101100, 101441, 101780, and 102193.
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 in emergency situations involving reversible apnea or cardiopulmonary arrest.
The affected devices were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee. Healthcare facilities and users should stop using the affected units and contact Ventlab Corporation for further instructions or replacement.
The recalled product
- Product
- Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is i
- 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 (12)
- Product List 071012
- Product Codes: SC9001C
- Lot #101360
- 101751
- 101819
- 101948
- 102090
- 102164 and SC9001C-C
- Lot #101100
- 101441
- 101780
- 102193.
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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