# FDA recall Z-0368-2024

> **SunMed Holdings, LLC** · Class II · device recall initiated 2023-10-11.

## 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, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH;     3.	Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN;     4.	Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN;     5.	Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.

## Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

## Distribution

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.

## Key facts

- **Recall number:** Z-0368-2024
- **Recalling firm:** SunMed Holdings, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-11
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0368-2024

## Citation

> AI Analytics. FDA recall Z-0368-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0368-2024. Source: US FDA. Licensed CC0.

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