The Recall Desk
HighFDA (Devices)·Z-0362-2024·Announced 2023-11-29

BreathTech Manual Resuscitators Recalled for Integrated Manometer Leak

SunMed Holdings is recalling BreathTech manual resuscitators because the integrated manometer can leak, allowing patients to rebreathe exhaled CO2 during emergency airway management.

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 is an FDA Class II medical device recall for a critical life-support product with a design defect (CO2 rebreathing) that poses a risk of patient harm. However, the source text does not report any associated illnesses, injuries, or hospitalizations, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

SunMed Holdings, LLC is recalling BreathTech manual resuscitators due to a defect in the integrated manometer that allows for CO2 rebreathing. The resuscitators, used for emergency airway management across multiple patient populations (adult, child, infant, and pediatric), have a backwards leak in the patient valve's manometer that permits patients to rebreathe exhaled carbon dioxide.

The recalled products include multiple model numbers (such as BT5107F, BT5104P, BT3030, BT3034, BT3025, and numerous infant and pediatric variants) and have been distributed nationwide across the United States. All units manufactured between September 21, 2018, and the present are affected, with expiration dates extending through October 2028.

Healthcare facilities and emergency responders should immediately identify potentially affected resuscitators using the model and UDI information provided in the FDA recall notice. Affected units should be removed from service. Facilities with affected devices should contact SunMed Holdings for further guidance.

The recalled product

Product
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant Res
Manufacturer
SunMed Holdings, LLC
Category
Medical Device — Emergency Airway Management Equipment
Hazard
  • co2-rebreathing
  • design-defect

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: 10889483090787 (Item # BT2014
  • Case UDI: 30889483090781)
  • UDI-DI: 10889483102046 (Item # BT2015
  • Case UDI: 30889483102040)
  • UDI-DI: 10889483097830 (Item # BT2016
  • Case UDI: 30889483097834)
  • UDI-DI: 10889483083246 (Item # BT2020
  • Case UDI: 30889483083240)
  • UDI-DI: 10889483083253 (Item # BT2023
  • Case UDI: 30889483083257)
  • UDI-DI: 10889483086339 (Item # BT2026
  • Case UDI: 30889483086333)
  • UDI-DI: 10889483091050 (Item # BT2027
  • Case UDI: 30889483091054)
  • UDI-DI: 10889483076170 (Item # BT2029
  • Case UDI: 30889483076174)
  • UDI-DI: 10889483077764 (Item # BT2032
  • Case UDI: 30889483077768)
  • UDI-DI: 10889483080108 (Item # BT2034
  • Case UDI: 30889483080102)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category