Reported Nov 29, 2023 · Ongoing
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.…
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 Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ |
| 2 | Horizon Infant Resuscitator REF #s: 6112HZ, 6123HZ, 6125HZ, 6200HZ, 6106HZ, 6118HZ, 6107HZ, 6013HZ, 6117HZ, 6116HZ, 6019HZ, HZI6000, 6009HZ |
| 3 | Horizon Pediatric Resuscitator REF #s: 8106HZ, 8119HZ, 8115HZ, 8107HZ, 8010HZ, 8004HZ, 8105HZ, 8113HZ, 8109HZ, 8116HZ, 8003HZ, HZI8100 |
- Lot codes and dates
- UDI-DI10889483166611 (Item # 6009HZ
- Case UDI30889483166615)
- UDI-DI10889483167786 (Item#: 6013HZ
- Case UDI30889483167780)
- UDI-DI10889483170786 (Item#: 6019HZ
- Case UDI30889483170780)
- UDI-DI10889483166437 (Item#: 6106HZ
- Case UDI30889483166431)
- UDI-DI10889483166444 (Item#: 6107HZ
- Case UDI30889483166448)
- UDI-DI10889483166499 (Item#: 6112HZ
- Case UDI30889483166493)
- UDI-DI10889483167779 (Item#:6116HZ
- Case UDI30889483167773)
- UDI-DI10889483167885 (Item#: 6117HZ
- Case UDI30889483167889)
- UDI-DI10889483168233 (Item # 6118HZ
- Case UDI30889483168237)
- UDI-DI10889483170199 (Item # 6123HZ
- Case UDI30889483170193)
- UDI-DI10889483171189 (Item # 6125HZ
- Case UDI30889483171183)
- UDI-DI10889483170984 (Item # 6200HZ
- Case UDI30889483170988)
- UDI-DI10889483166680 (Item # 8003HZ
- Case UDI30889483166684)
- UDI-DI10889483166697 (Item # 8004HZ
- Case UDI30889483166691)
- UDI-DI10889483230831(Item # 8010HZ
- Case UDI30889483230834)
- UDI-DI10889483172650 (Item # 8105HZ
- Case UDI30889483172654)
- UDI-DI10889483166741(Item # 8106HZ
- Case UDI30889483166745)
- UDI-DI10889483166758 (Item # 8107HZ
- Case UDI30889483166752)
- UDI-DI10889483166772 (Item # 8109HZ
- Case UDI30889483166776)
- UDI-DI10889483166819 (Item # 8113HZ
- Case UDI30889483166813)
- UDI-DI10889483169117 (Item # 8115HZ
- Case UDI30889483169111)
- UDI-DI10889483167908 (Item # 8116HZ
- Case UDI30889483167902)
- UDI-DI10889483171196 (Item # 8119HZ
- Case UDI30889483171190)
- UDI-DI10889483166291 (Item # 9002HZ
- Case UDI30889483166295)
- UDI-DI10889483166338 (Item # 9006HZ
- Case UDI30889483166332)
- UDI-DI10889483165638 (Item # 9100HZ
- Case UDI30889483165632)
- UDI-DI10889483165676 (Item # 9105HZ
- Case UDI30889483165670)
- UDI-DI10889483165683 (Item # 9106HZ
- Case UDI30889483165687)
- UDI-DI10889483165706 (Item # 9108HZ
- Case UDI30889483165700)
- UDI-DI10889483165720 (Item # 9110HZ
- Case UDI30889483165724)
- UDI-DI10889483165737 (Item # 9111HZ
- Case UDI30889483165731)
- UDI-DI10889483171202 (Item # 9120HZ
- Case UDI30889483171206)
- UDI-DI10889483230688 (Item # 9122HZ
- Case UDI30889483230682)
- UDI-DI10889483167199 (Item # HZI600
- Case UDI30889483167193)
- UDI-DI10889483167307 (Item # HZI8100
- Case UDI30889483167308)
- UDI-DI10889483167236 (Item # HZI9000
- Case UDI30889483167230)
- UDI-DI10889483167793 (Item # HZI9108
- Case UDI30889483167787) 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.
Want the full recall guide?
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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