CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report
Ventlab, LLC RescuMed manual resuscitators recalled by SunMed Holdings
SunMed Holdings is recalling Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory, distributed nationwide in the US. The recall was initiated on 11 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0364-2024
- FDA event ID
- 93237
- Recalling firm
- SunMed Holdings, Grand Rapids, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Oct 2023
- FDA classified
- 21 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 11 Oct 2023 | Recall initiated by company | |
| 21 Nov 2023 | Classified by FDA | +41 days |
| 29 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMinnesotaNorth CarolinaNorth DakotaNew Hampshire
Questions about this recall
Is Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory recalled?
Yes. SunMed Holdings recalled Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory on 11 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0364-2024.
Why was it recalled?
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Which lots are affected?
UDI-DI: 10889483164266, (ITEM # BVM510-F, Case UDI: 30889483184680); UDI-D: 10889483164754, (ITEM # BVMB710, Case UDI: 30889483164758); UDI-DI: 10889483164785, (ITEM # BVMB812, Case UDI: 30889483164789); UDI-DI: 10889483164761, (ITEM # BVMB812-F, Case UDI: 30889483164765); UDI-DI: 10889483169605, (ITEM # BVMB510-10, Case UDI: 30889483169609); UDI-DI: 10889483164686, (ITEM # BVMB510-F, Case UDI: 0889483164680); UDI-DI: 10889483164693, (ITEM # BVMB510S-F, Case UDI: 3088948316469); UDI-DI: 10889483164747, (ITEM # BVMB710-F, Case UDI: 30889483164741); UDI-DI: 10889483164730, (ITEM # BVMB810, Case UDI: 30889483164734); UDI-DI: 10889483164716, (ITEM # BVMB810-F, Case UDI: 30889483164710); UDI-DI: 10889483164723, (ITEM # BVMB810S-F, Case UDI: 30889483164727). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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