Reported Nov 29, 2023 · Ongoing
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include:…
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 BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include
4 of 4 products
| # | Product as published |
|---|---|
| 1 | BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P |
| 2 | BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025 |
| 3 | BreathTech Infant Resuscitator REF #s: BT2415K, BT2416, BT2032, BT2016, BT2035, BT2216, BT2036, BT2023, BT2026, BT2220-2, BT2020, BT2220, BT2220F, BT2215, BT2415, BT2014, BT2027, BT2015, BT2029, BT2037, BT2048, BT2034, BT2034W, BT2234, BT2234FK |
| 4 | BreathTech Pediatric Resuscitator REF #s: BT4016, BT4019, BT4013, BT4018, BT4013F, BT4015, BT4006-N, BT4040, BT4022, BT4045, BT4024. |
- Lot codes and dates
41 of 41 products
Products covered by this recall Model / number Barcodes Product as published BT2014108894830907873088948309078110889483090787 ( , Case UDI: 30889483090781) BT20151088948310204630889483102040UDI-DI: 10889483102046 ( , Case UDI: 30889483102040) BT20161088948309783030889483097834UDI-DI: 10889483097830 ( , Case UDI: 30889483097834) BT20201088948308324630889483083240UDI-DI: 10889483083246 ( , Case UDI: 30889483083240) BT20231088948308325330889483083257UDI-DI: 10889483083253 ( , Case UDI: 30889483083257) BT20261088948308633930889483086333UDI-DI: 10889483086339 ( , Case UDI: 30889483086333) BT20271088948309105030889483091054UDI-DI: 10889483091050 ( , Case UDI: 30889483091054) BT20291088948307617030889483076174UDI-DI: 10889483076170 ( , Case UDI: 30889483076174) BT20321088948307776430889483077768UDI-DI: 10889483077764 ( , Case UDI: 30889483077768) BT20341088948308010830889483080102UDI-DI: 10889483080108 ( , Case UDI: 30889483080102) BT2034W1088948308057330889483080577UDI-DI: 10889483080573 ( , Case UDI: 30889483080577) BT20351088948309288030889483092884UDI-DI: 10889483092880 ( , Case UDI: 30889483092884) BT20361088948309079430889483090798UDI-DI: 10889483090794 ( , Case UDI: 30889483090798) BT20371088948308327730889480832771UDI-DI: 10889483083277 ( , Case UDI: 30889480832771) BT20481088948307885330889483078857UDI-DI: 10889483078853 ( , Case UDI: 30889483078857) BT22151088948310603730889483106031UDI-DI: 10889483106037 ( , Case UDI: 30889483106031) BT22161088948310114830889483101142UDI-DI: 10889483101148 ( , Case UDI: 30889483101142) BT22201088948310086830889483100862UDI-DI: 10889483100868 ( , Case UDI: 30889483100862) BT2220-21088948308011530889483080119UDI-DI: 10889483080115 ( , Case UDI: 30889483080119) BT2220F1088948308899930889483088993UDI-DI: 10889483088999 ( , Case UDI: 30889483088993) - 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.
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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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