The Recall Desk
HighFDA (Devices)·Z-0365-2024·Announced 2023-11-29

SafeSpot Manual Resuscitators Recalled for CO2 Rebreathing Risk

SunMed Holdings is recalling SafeSpot manual resuscitators with integrated manometers due to a backwards leak that allows CO2 rebreathing. The defect affects multiple accessory configurations 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 is an FDA Class II recall of a critical respiratory medical device with a design defect (backwards leak in manometer) that creates a significant physiological hazard (CO2 rebreathing). While no illnesses or injuries are reported in the source text, the potential for serious respiratory compromise in a resuscitator device justifies a High severity classification per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

SunMed Holdings, LLC is recalling SafeSpot manual resuscitators with integrated manometer and multiple accessory configurations. The devices are affected by a backwards leak present in the integrated manometer of the patient valve that allows for CO2 rebreathing.

CO2 rebreathing occurs when exhaled carbon dioxide is reinhaled instead of being properly vented, which can compromise respiratory function. This defect affects multiple SafeSpot resuscitator models including infant resuscitators and accessory kits with model reference numbers such as SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, and others.

The affected products were distributed nationwide throughout the United States, including in Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia, and West Virginia.

If you have one of these resuscitators, contact SunMed Holdings or the FDA for further instructions regarding the recall.

The recalled product

Product
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, S
Manufacturer
SunMed Holdings, LLC
Category
Medical Device — Respiratory / Resuscitation Equipment
Hazard

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: 10889483104107
  • (Case UDI: 30889483104105
  • Item # PRO-1927)
  • UDI-DI: 10889483102954
  • (Case UDI: 30889483102958
  • Item # SS3200MB)
  • UDI-DI: 10889483092590
  • (Case UDI: 30889483092594
  • Item # SS3200MB-2)
  • UDI-DI: 10889483104330
  • (Case UDI: 30889483104334
  • Item #SS3200MB-D1)
  • UDI-DI: 10889483172322
  • (Case UDI: 30889483172326
  • Item # SS3200MBF)
  • UDI-DI: 10889483104354
  • (Case UDI: 30889483104358
  • Item # SS3200MBF-2)
  • UDI-DI: 10889483104545
  • (Case UDI: 30889483104549

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Part of a larger recall action

This product is one of 9 recalled by SunMed Holdings, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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