Recall Z-0364-2024— SunMed Holdings, LLC

Name: FDA recall Z-0364-2024
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: Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMed Pediatric Resuscitator REF #s: BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F.. 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

Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMed Pediatric Resuscitator REF #s: BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F.

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.