Z-0367-2024Class II

Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to...

Name: Z-0367-2024 Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to...
Creator: SunMed Holdings, LLC
Published: 2023-10-11
License: https://open.fda.gov/license/

Salter Labs / initiated 2023-10-11 / Open, Classified / root cause: design

FDA source

SunMed Holdings, LLC began a recall of Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s... on 2023-10-11. FDA classified it as Class II and gives the reason as "A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0367-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-11
Posted: 2023-11-21
Recalling firm: Salter Labs
Product: Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, VN3100MBP-3M, VN3100MB, VN3100MB-D1, VN3100MB-M00-0, VN3100MB-M1, VN3100OBP, VN3100MB-B, VN3100MB-I, VN3100MBP-000, VN3100MBP-2, VN3100MB-PW2, VN3100MBP, VN3100MBP-D1, VN3100MBPW-D2, VN3100MBP-F, VN3100MXK-2, VN3100MX-F, VN3100MC-2, VN3100MC, VN3100MC-B, VN3100MC-D1, VN3100MC-2U, VN3106MC-M1-2V, VN3104MCFB- M01, VN3106MC-D2V, VN3106MC-M1V, VN3100MCP-2, VN3100MCP, VN3106MCPF- M1V, VN3100MBF; 3. V-Care Pediatric Resuscitator REF #s: VN2100MB, VN2102MB, VN2102MBF, VN2102OBP, VN2100MBF, VN2100MBP, VN2100MB-PW, VN2102MX, VN2102MX-F, VN2100MX-M123, VN2100MC, VN2102MC, VN2102MC-B, VN2102MCP, VN2100MCP; 4. V-Care Small Adult Resuscitator REF #s: VN5000MB, VN5002MB, VN5100MB-F, VN5000MBPF, VN5000MBPF-I, VN5000MX, VN5100MX-F, VN5000MX-N, VN5000MXP, VN5000MXP-K, VN5000MC, VN5102MC, VN5100MCP, VN5000MC-N.
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Root cause tag: design
FDA root cause: Device Design
Action: Customer notification was emailed October 11, 2023 advising customers that monitoring of tidal carbon dioxide in critically ill patients is recommended because use of accessories (e.g. PEEP valve) on the exhalation port of manual resuscitators may increase backward leak in the integrated manometer due to increased expiratory resistance. This affects all lots with duckbill-style patient valve with integrated manometer manufactured since 09/21/2019. Customers are to disseminate this information to all users and complete and return the response for. The notice also notes manual resuscitator IFUs will be updated to include this information as a warning statement.
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.
Product codes and lots: ITEM # VN2100MB, UDI-DI: 10889483095379, (Case UDI: 30889483095373); ITEM # VN2100MBF, UDI-DI: 10889483092774, (Case UDI: 30889483092778); ITEM # VN2100MBP, UDI-DI: 10889483108260, (Case UDI: 30889483108264); ITEM # VN2100MB-PW, UDI-DI: 10889483108253, (Case UDI: 30889483108257); ITEM # VN2100MC, UDI-DI: 10889483108277, (Case UDI: 30889483108271); ITEM # VN2100MCP, UDI-DI: 10889483094525, (Case UDI: 30889483094529); ITEM # VN2100MX-M123, UDI-DI: 10889483098936, (Case UDI: 30889483098930); ITEM # VN2102MB, UDI-DI: 10889483105542, (Case UDI: 30889483105546); ITEM # VN2102MBF, UDI-DI: 10889483110966, (Case UDI: 30889483110960); ITEM # VN2102MC, UDI-DI: 10889483111994, (Case UDI: 30889483111998); ITEM # VN2102MC-B, UDI-DI: 10889483107393, (Case UDI: 30889483107397); ITEM # VN2102MCP, UDI-DI: 10889483088470, (Case UDI: 30889483088474); ITEM # VN2102MX, UDI-DI: 10889483095751, (Case UDI: 30889483095755); ITEM # VN2102MX-F, UDI-DI: 10889483105863, (Case UDI: 30889483105867); ITEM # VN2102OBP, UDI-DI: 10889483108895, (Case UDI: 30889483108899); ITEM # VN3100MB, UDI-DI: 10889483096994, (Case UDI: 30889483096998); ITEM # VN3100MB-2, UDI-DI: 10889483105900, (Case UDI: 30889483105904); ITEM # VN3100MB-B, UDI-DI: 10889483113585, (Case UDI: 30889483113589); ITEM # VN3100MB-D1, UDI-DI: 10889483105566, (Case UDI: 30889483105560); ITEM # VN3100MBF, UDI-DI: 10889483100622, (Case UDI: 30889483100626); ITEM # VN3100MB-I, UDI-DI: 10889483109380, (Case UDI: 30889483109384); ITEM # VN3100MB-M00- 0, UDI-DI: 10889483095980, (Case UDI: 30889483095984); ITEM # VN3100MB-M01, UDI-DI: 10889483110386, (Case UDI: 30889483110380); ITEM # VN3100MB-M1, UDI-DI: 10889483102763, (Case UDI: 30889483102767); ITEM # VN3100MBP, UDI-DI: 10889483100622, (Case UDI: 30889483100626); ITEM # VN3100MBP-000, UDI-DI: 10889483110393, (Case UDI: 30889483110397); ITEM # VN3100MBP-2, UDI-DI: 10889483104262, (Case UDI: 30889483104266); ITEM # VN3100MBP-3M, UDI-DI: 10889483100639, (Case UDI: 30889483100633); ITEM # VN3100MBP-D1, UDI-DI: 10889483110751, (Case UDI: 30889483110755); ITEM # VN3100MBP-F, UDI-DI: 10889483102770, (Case UDI: 30889483102774); ITEM # VN3100MB-PW2, UDI-DI: 10889483110744, (Case UDI: 30889483110748); ITEM # VN3100MBPW-D2, UDI-DI: 10889483111192, (Case UDI: 30889483111196); ITEM # VN3100MC, UDI-DI: 10889483100646, (Case UDI: 30889483100640); ITEM # VN3100MC-2, UDI-DI: 10889483111208, (Case UDI: 30889483111202); ITEM # VN3100MC-2U, UDI-DI: 10889483112113, (Case UDI: 30889483112117); ITEM # VN3100MC-B, UDI-DI: 10889483095768, (Case UDI: 30889483095762); ITEM # VN3100MC-D1, UDI-DI: 10889483112021, (Case UDI: 30889483112025); ITEM # VN3100MCP, UDI-DI: 10889483110768, (Case UDI: 30889483110762); ITEM # VN3100MCP-2, UDI-DI: 10889483113622, (Case UDI: 30889483113626); ITEM # VN3100MX-F, UDI-DI: 10889483112038, (Case UDI: 30889483112032); ITEM # VN3100MXK-2, UDI-DI: 10889483111215, (Case UDI: 30889483111219); ITEM # VN3100OB, UDI-DI: 10889483099964, (Case UDI: 30889483099968); ITEM # VN3100OBP, UDI-DI: 10889483105924, (Case UDI: 30889483105928); ITEM # VN3104MCFB- M01, UDI-DI: 10889483110775, (Case UDI: 30889483110779); ITEM # VN3106MC-D2V, UDI-DI: 10889483107539, (Case UDI: 30889483107533); ITEM # VN3106MC-M1- 2V, UDI-DI: 10889483095997, (Case UDI: 30889483095991); ITEM # VN3106MC-M1V, UDI-DI: 10889483097991, (Case UDI: 30889483097995); ITEM # VN3106MCPF- M1V, UDI-DI: 10889483099001, (Case UDI: 30889483099005); ITEM # VN4100MB, UDI-DI: 10889483111338, (Case UDI: 30889483111332); ITEM # VN4100MCFB-3, UDI-DI: 10889483111239, (Case UDI: 30889483111233); ITEM # VN4100MCP, UDI-DI: 10889483098042, (Case UDI: 30889483098046); ITEM # VN5000MB, UDI-DI: 10889483112052, (Case UDI: 30889483112056); ITEM # VN5000MBPF, UDI-DI: 10889483112229, (Case UDI: 30889483112223); ITEM # VN5000MBPF-I, UDI-DI: 10889483113646, (Case UDI: 30889483113640); ITEM # VN5000MC, UDI-DI: 10889483095393, (Case UDI: 30889483095397); ITEM # VN5000MC-N, UDI-DI: 10889483108352, (Case UDI: 30889483108356); ITEM # VN5000MX, UDI-DI: 10889483107782, (Case UDI: 30889483107786); ITEM # VN5000MX-N, UDI-DI: 10889483107553, (Case UDI: 30889483107557); ITEM # VN5000MXP, UDI-DI: 10889483089828, (Case UDI: 30889483089822); ITEM # VN5000MXP-K, UDI-DI: 10889483110409, (Case UDI: 30889483110403); ITEM # VN5002MB, UDI-DI: 10889483100660, (Case UDI: 30889483100664); ITEM # VN5100MB-F, UDI-DI: 10889483107560, (Case UDI: 30889483107564); ITEM # VN5100MCP, UDI-DI: 10889483098554, (Case UDI: 30889483098558); ITEM # VN5100MX-F, UDI-DI: 10889483095782, (Case UDI: 30889483095786); ITEM # VN5102MC, UDI-DI: 10889483109403, (Case UDI: 30889483109407); ITEM # VNW3100MB-2, UDI-DI: 10889483100677, (Case UDI: 30889483100671). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0367-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0361-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0362-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0363-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0364-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0365-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0366-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0367-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0368-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0369-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21

Product code BTM

K012842Class IIV*care Manual ResuscitatorVentlab Corp. / cleared 2001-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)