Reported Nov 29, 2023 · Ongoing
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to…
SunMed Holdings, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SunMed Holdings, LLC · 2710 Northridge Dr Nw Ste A · Grand Rapids, MI · 49544-9112
Is this the product you have?
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include
6 of 6 products
| Model / number | Product as published |
|---|---|
| — | 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 |
| — | AirFlow Child Resuscitator REF #s: AF4100MCP, AF4140MB, AF4140MB-I, AF4140MBP, AF4140MB-PI, AF4100MB, AF4100MBP, AF4100OB, AF4140MB-D23, AF4140OBP, AF4140MCP-D3, AF4140MC |
| — | AirFlow Infant Resuscitator REF #s: AF3140OB, AF3144MB, AF3104MB-PW, AF3100MBP- M0D1, AF3100MBP- M012, AF3140MB-M000, AF3140MB-D2, AF3140MB-D1, AF3140MB-S1, AF3140MB-2B, AF3140MB-I, AF3140MB-K, AF3100MB-PW, AF3100MB-PTS1, AF3100MB-M0- D1, AF3100OC, AF3100MC-2, AF3100MC, AF3106MC-2, AF3140MCP-K, AF3140MC-2B, AF3100MCP-2, AF3140MC- M0D12, AF3144MCP- M1M00, AF3100OB, AF3140MB, AF3140MB-M0, AF3140MB-2, AF3140MB-M1, AF3140MB-PW, AF3140MB-P, AF3140MB-D12I, AF3140MBP-2, AF3140MC, AF3140MCP, AF3140MCPF, AF3100MB, AF3100MB-M0, AF3100MB-2, AF3100MB-M1, AF3100MB-X, AF3100MBP, AF3100MB-M01, AF3100MBP-M01, AF3100MBP-2, AF3100MBP-D12, AF3100MCP |
| — | AirFlow Pediatric Resuscitator REF #s: AF2100OB, AF2100MB-3, AF2102OB, AF2100MB-D5, AF2140OB, AF2102MBP-2, AF2102MBPW-D4, AF2102MBP-M3, AF2140MB-2, AFW2142OB, AF2140MB-D4, AF2140MB-D43, AF2140MB-P2, AF2144MB, AFW2142MB-2, AF2142MB-D3, AF2242MBP, AF2142MBS-I, AF2142MBP- 224OT, AF2140MBPW- D23, AF2140MB-I, AF2140MB-K, AF2140MB-S, AF2140MBP-K, AF2100MB-PW, AF2100MB-MMC, AF2102MBP, AF2100MB- PWTS4, AF2140MCPF, AF2100MC, AF2102MC, AF2142MC-M01, AF2140MC, AF2142MC-D34, AF2140MCP-D4, AF2140MC-PT, AF2140MCP-K, AF2142MCP, AF2100MCP, AF2102MB, AF2102MCP, AF2102MC-PT, AF2142OB, AF2142OBNS, AF2142MB, AF2142MB-3, AF2142MB-2, AF2142MB-M5E, AF2142MB-PW, AF2142MBP, AF2142MB-K, AF2142MBP-2, AF2142MC-3, AF2142MCP-D4, AF2140MB, AF2140MB-PW, AF2140MBP, AF1142OB, AF2100MB |
| — | AirFlow Small Adult Resuscitator REF #s: AF5140MC-D6, AF5140MB-M5, AF5100MB-D5, AF5142MBP-M5, AF5140MBPW-D5, AF5140MBPWTD5, AF5140MBP-D5, AF5140MBP-D6, AF5140MBPW- M5, AF5140MBP-M5, AFN5140MB, AF5140MB-OT, AF5140MB-T, AFD5140MB-T, AF5140MB-K, AF5140MBS-R, AF5140MBS-P, AF5140MB-PT, AF5140MB-ST, AF5140MCP-K, AF5100MB-PW, AF5102MB-N, AF5140MBS-M5. |
MC1000. | Ventlab, LLC Resuscitation Kit |
- Lot codes and dates
199 of 199 products
Products covered by this recall Model / number Barcodes Product as published AF1000MBN-20108894830758143088948307581810889483075814 ( , Case UDI: 30889483075818) AF1100MB1088948307660630889483076600UDI-DI: 10889483076606 ( , Case UDI: 30889483076600) AF1100MB-MMC1088948307661330889483076617UDI-DI: 10889483076613 ( , Case UDI: 30889483076617) AF1100MB-N1088948307583830889483075832UDI-DI: 10889483075838 ( , Case UDI: 30889483075832) AF1100MBP1088948308807430889483088078UDI-DI: 10889483088074 ( , Case UDI: 30889483088078) AF1100MB-PWG11088948308620930889483086203UDI-DI: 10889483086209 ( , Case UDI: 30889483086203) AF1100MBS1088948308621630889483086210UDI-DI: 10889483086216 ( , Case UDI: 30889483086210) AF1100MC1088948309436530889483094369UDI-DI: 10889483094365 ( , Case UDI: 30889483094369) AF1100MC-P1088948315921730889483159211UDI-DI: 10889483159217 ( , Case UDI: 30889483159211) AF1140MB1088948307180930889483071803UDI-DI: 10889483071809 ( , Case UDI: 30889483071803) AF1140MBC-N1088948323062630889483230620UDI-DI: 10889483230626 ( Case UDI: 30889483230620) AF1140MB-D51088948309071830889483090712UDI-DI: 10889483090718 ( , Case UDI: 30889483090712) AF1140MB-E1088948310637230889483106376UDI-DI: 10889483106372 ( , Case UDI: 30889483106376) AF1140MB-I1088948309509630889483095090UDI-DI: 10889483095096 ( , Case UDI: 30889483095090) AF1140MB-K1088948308391830889483083912UDI-DI: 10889483083918 ( , Case UDI: 30889483083912) AF1140MB-M51088948316222430889483162228UDI-DI: 10889483162224 ( , Case UDI: 30889483162228) AF1140MB-N1088948309437230889483094376UDI-DI: 10889483094372 ( , Case UDI: 30889483094376) AF1140MB-P1088948309837030889483098374UDI-DI: 10889483098370 ( , Case UDI: 30889483098374) AF1140MBP-21088948310146930889483101463UDI-DI: 10889483101469 ( , Case UDI: 30889483101463) AF1140MBP-K1088948310639630889483106390UDI-DI: 10889483106396 ( , Case UDI: 30889483106390) - Amount recalled
- N/A
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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