The Recall Desk
HighFDA (Devices)·Z-0363-2024·Announced 2023-11-29

Horizon manual resuscitators recalled for CO2 rebreathing hazard

SunMed Holdings is recalling Ventlab Horizon manual resuscitators due to a backwards leak in the integrated manometer that allows carbon dioxide rebreathing. The affected devices were manufactured from September 2018 to the present and distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall involves a serious potential hazard—a backwards leak in the integrated manometer enabling carbon dioxide rebreathing—but no illnesses, injuries, or adverse events have been reported. Per the severity rubric, risk-of-harm products without reported injury are rated High (3).

Plain-English summary

Ventlab, LLC Horizon manual resuscitators with integrated manometers are being recalled by manufacturer SunMed Holdings, LLC. The recall covers adult, infant, and pediatric models with multiple reference numbers for each size category. The devices were manufactured from September 21, 2018 to the present.

A backwards leak in the integrated manometer's patient valve allows for carbon dioxide rebreathing. This defect is present in all units manufactured during the affected period.

The recalled resuscitators were distributed nationwide across the United States to 28 states. This is a Class II recall issued by the U.S. Food and Drug Administration under recall number Z-0363-2024.

Healthcare facilities, emergency services, and other users of these devices should contact SunMed Holdings, LLC for further information and guidance regarding the recalled resuscitators.

The recalled product

Product
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resu
Manufacturer
SunMed Holdings, LLC
Category
Medical Device — Resuscitators
Hazard
  • co2-rebreathing

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)

  • UDI-DI: 10889483166611 (Item # 6009HZ
  • Case UDI: 30889483166615) UDI-DI: 10889483167786 (Item#: 6013HZ
  • Case UDI: 30889483167780) UDI-DI: 10889483170786 (Item#: 6019HZ
  • Case UDI: 30889483170780) UDI-DI: 10889483166437 (Item#: 6106HZ
  • Case UDI: 30889483166431) UDI-DI: 10889483166444 (Item#: 6107HZ
  • Case UDI: 30889483166448) UDI-DI: 10889483166499 (Item#: 6112HZ
  • Case UDI: 30889483166493) UDI-DI: 10889483167779 (Item#:6116HZ
  • Case UDI: 30889483167773) UDI-DI: 10889483167885 (Item#: 6117HZ
  • Case UDI: 30889483167889) UDI-DI: 10889483168233 (Item # 6118HZ
  • Case UDI: 30889483168237) UDI-DI: 10889483170199 (Item # 6123HZ
  • Case UDI: 30889483170193) UDI-DI: 10889483171189 (Item # 6125HZ
  • Case UDI: 30889483171183) UDI-DI: 10889483170984 (Item # 6200HZ
  • Case UDI: 30889483170988) UDI-DI: 10889483166680 (Item # 8003HZ
  • Case UDI: 30889483166684) UDI-DI: 10889483166697 (Item # 8004HZ
  • Case UDI: 30889483166691) UDI-DI: 10889483230831(Item # 8010HZ
  • Case UDI: 30889483230834) UDI-DI: 10889483172650 (Item # 8105HZ
  • Case UDI: 30889483172654) UDI-DI: 10889483166741(Item # 8106HZ
  • Case UDI: 30889483166745) UDI-DI: 10889483166758 (Item # 8107HZ
  • Case UDI: 30889483166752) UDI-DI: 10889483166772 (Item # 8109HZ
  • Case UDI: 30889483166776) UDI-DI: 10889483166819 (Item # 8113HZ

Distribution

Distributed nationwide across the United States.

Related recalls

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