The Recall Desk
HighFDA (Devices)·Z-0368-2024·Announced 2023-11-29

Curaplex Manual Resuscitators Recalled for Potential CO2 Rebreathing Risk

SunMed Holdings is recalling Curaplex manual resuscitators with integrated manometers due to a backwards leak in the patient valve that allows carbon dioxide rebreathing. All units manufactured from September 2018 to present and distributed nationwide are affected.

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 with no reported illnesses or injuries. The defect creates a risk of CO2 rebreathing in a critical respiratory device, but no actual harm has been documented. This qualifies as High severity per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

SunMed Holdings, LLC is recalling Curaplex manual resuscitators (bag-valve-mask devices) with integrated manometers. The recall affects multiple product configurations including Adult Premium BVM, Child Premium BVM, Infant Premium BVM, and Small Adult Pediatric models with various mask and accessory combinations.

The recall was initiated because a backwards leak in the integrated manometer of the patient valve allows carbon dioxide (CO2) rebreathing during manual ventilation. This defect creates a risk that the device may not effectively deliver fresh air and ventilation to patients.

All units manufactured from September 21, 2018 to present are included in the recall. The affected devices were distributed nationwide across 30 states, including 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.

Healthcare facilities and emergency responders should verify their inventory against the FDA recall notice (Z-0368-2024) using the provided UDI-DI and item reference numbers to determine whether replacement or repair is needed.

The recalled product

Product
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 2
Manufacturer
SunMed Holdings, LLC
Category
Medical Device — Respiratory / Resuscitation
Hazard
  • co2-rebreathing
  • manometer-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 (9)

  • UDI-DI: 00810071633126
  • Item # 2442-BVMCIN
  • UDI-DI: 00812277037050
  • Item # 2442-BVMPAD
  • UDI-DI: 00812277037074
  • Item # 2442-BVMPCH
  • UDI-DI: 00812277037081
  • Item # 2442-BVMPIN
  • UDI-DI: 00812277037067

Distribution

Distributed nationwide across the United States.

Related recalls

Same category