The Recall Desk
HighFDA (Devices)·Z-0361-2024·Announced 2023-11-29

Ventlab AirFlow Manual Resuscitators Recalled for CO2 Rebreathing Risk

SunMed Holdings is recalling Ventlab AirFlow manual resuscitators nationwide due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Users should immediately discontinue use and contact the manufacturer.

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 a Class II FDA device recall for a documented functional defect in a critical medical device used for manual patient ventilation. The backwards leak in the manometer allows CO2 rebreathing, which impairs ventilation and constitutes a risk-of-harm in a life-support device.

Plain-English summary

SunMed Holdings, LLC is recalling Ventlab AirFlow manual resuscitators with integrated manometers. A backwards leak in the patient valve's integrated manometer allows for CO2 rebreathing, which impairs the device's ability to provide adequate ventilation.

The recall affects multiple AirFlow model configurations including Adult, Child, Infant, Pediatric, and Small Adult Resuscitators, as well as associated Resuscitation Kits. Affected devices were manufactured from September 2018 to present and distributed nationwide across the United States.

Users should immediately discontinue use of affected devices. Contact SunMed Holdings, LLC or the relevant healthcare facility for device replacement or further instructions regarding these recalled resuscitators.

The recalled product

Product
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6
Manufacturer
SunMed Holdings, LLC
Category
Medical Device — Respiratory Equipment
Hazard
  • co2-rebreathing
  • ventilation-failure

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: 10889483075814 (Item # AF1000MBN-20
  • Case UDI: 30889483075818)
  • UDI-DI: 10889483076606 (Item # AF1100MB
  • Case UDI: 30889483076600)
  • UDI-DI: 10889483076613 (Item # AF1100MB-MMC
  • Case UDI: 30889483076617)
  • UDI-DI: 10889483075838 (Item # AF1100MB-N
  • Case UDI: 30889483075832)
  • UDI-DI: 10889483088074 (Item # AF1100MBP
  • Case UDI: 30889483088078)
  • UDI-DI: 10889483086209 (Item # AF1100MB-PWG1
  • Case UDI: 30889483086203)
  • UDI-DI: 10889483086216 (Item # AF1100MBS
  • Case UDI: 30889483086210)
  • UDI-DI: 10889483094365 (Item # AF1100MC
  • Case UDI: 30889483094369)
  • UDI-DI: 10889483159217 (Item # AF1100MC-P
  • Case UDI: 30889483159211)
  • UDI-DI: 10889483071809 (Item # AF1140MB
  • Case UDI: 30889483071803)

Distribution

Distributed nationwide across the United States.

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