Reported Nov 29, 2023 · Ongoing
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include:…
SunMed Holdings, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SunMed Holdings, LLC · 2710 Northridge Dr Nw Ste A · Grand Rapids, MI · 49544-9112
Is this the product you have?
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include
3 of 3 products
| # | Product as published |
|---|---|
| 1 | STAT-Check Adult Resuscitator REF #: SC9101B |
| 2 | STAT-Check Infant Resuscitator RES #s: SC7101B & SC7101B-M0 |
| 3 | STAT-Check Pediatric Resuscitator REF #: SC8121B. |
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published SC7101B108894831092503088948310925410889483109250, ( , Case UDI: 30889483109254) SC7101B-M0.1088948316067130889483160675UDI-DI: 10889483160671, ( Case UDI: 30889483160675) SC8121B1088948311004130889483110045UDI-DI: 10889483110041, ( , Case UDI: 30889483110045) SC9101B1088948309867730889483098671UDI-DI: 10889483098677, ( , Case UDI: 30889483098671). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028. - Amount recalled
- N/A
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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