medical Class II Updated 2023-11-29

SunMed Holdings, LLC recalls Ventlab, LLC Horizon manual resuscitators with integrated ma

Recalled 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 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;

Hazard / Issue

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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, Case UDI: 30889483166813) UDI-DI: 10889483169117 (Item # 8115HZ, Case UDI: 30889483169111) UDI-DI: 10889483167908 (Item # 8116HZ, Case UDI: 30889483167902) UDI-DI: 10889483171196 (Item # 8119HZ, Case UDI: 30889483171190) UDI-DI: 10889483166291 (Item # 9002HZ, Case UDI: 30889483166295) UDI-DI: 10889483166338 (Item # 9006HZ, Case UDI: 30889483166332) UDI-DI: 10889483165638 (Item # 9100HZ, Case UDI: 30889483165632) UDI-DI: 10889483165676 (Item # 9105HZ, Case UDI: 30889483165670) UDI-DI: 10889483165683 (Item # 9106HZ, Case UDI: 30889483165687) UDI-DI: 10889483165706 (Item # 9108HZ, Case UDI: 30889483165700) UDI-DI: 10889483165720 (Item # 9110HZ, Case UDI: 30889483165724) UDI-DI: 10889483165737 (Item # 9111HZ, Case UDI: 30889483165731) UDI-DI: 10889483171202 (Item # 9120HZ, Case UDI: 30889483171206) UDI-DI: 10889483230688 (Item # 9122HZ, Case UDI: 30889483230682) UDI-DI: 10889483167199 (Item # HZI600, Case UDI: 30889483167193) UDI-DI:10889483167307 (Item # HZI8100, Case UDI: 30889483167308) UDI-DI: 10889483167236 (Item # HZI9000, Case UDI: 30889483167230) UDI-DI: 10889483167793 (Item # HZI9108, Case UDI: 30889483167787) All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.
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