medical Class II Updated 2023-11-29

SunMed Holdings, LLC recalls Curaplex manual resuscitators with integrated manometer, mul

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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, Item # 2442-BVMPSA. All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.
View official government recall

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