Z-0363-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- October 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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;
Reason for Recall
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Distribution Pattern
US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
Code Information
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.