FDA recall Z-0361-2024

SunMed Holdings, LLC · Class II · device

Product

Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T, AF1140MB-PW, AF5140MB-PW, AF1140MB-I, AF5140MB-I, AF5140MBN, AF1140MBS, AF5140MBS, AF1140MB-X, AF5140MB-X, AF1140MB-P, AF5140MBP, AF1140MB-K, AF5140MBS-I,AF5140MBPF-G10, AF5140MBP-G10, AF1140MBP-T, AF5140MBP-I, AF1140MBP-K, AF1140MBC-N, AF1140MBP-2, AF1140MC, AF5140MC, AF1140MCP, AF5140MC-P, AF1100MB, AF5100MB, AF5100MC, AF1140MC-M5, AF1140MB-TM5, AF1140MBP-TM5, AF1100MC, AF1140OB, AF1140MBP-M5, AFW1140MB,AF1140MBS-P, AF1000MBN-20, AF5102MBP, AF1100MB-N, AF1100MC-P, AF1140MB, AF1140MB-E, AF1140MB-N, AF1140MB-R, AF1140MBS-K, AF1140MBSP-I, AF1142MB, AF1100MBS, AF1100MB-MMC, AF1100MB-PWG1, AF1100MBP; 2. AirFlow Child Resuscitator REF #s: AF4100MCP, AF4140MB, AF4140MB-I, AF4140MBP, AF4

Reason for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2023-10-11
Report date
2023-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0361-2024