Recall Z-0368-2024— SunMed Holdings, LLC

Name: FDA recall Z-0368-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-11

Class II · Ongoing

Class II FDA medical device recall by SunMed Holdings, LLC, initiated 2023-10-11. It names one FDA 510(k) clearance: K012842. 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: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing..

Recalling firm: SunMed Holdings, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-10-11
Firm location: Grand Rapids, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K012842 — V*CARE MANUAL RESUSCITATORVentlab Corp.·cleared 2001-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.