medical Class II Updated 2023-11-29

SunMed Holdings, LLC recalls Ventlab, LLC BreathTech manual resuscitators with integrated

Recalled Product

Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 10889483090787 (Item # BT2014, Case UDI: 30889483090781); UDI-DI: 10889483102046 (Item # BT2015, Case UDI: 30889483102040); UDI-DI: 10889483097830 (Item # BT2016, Case UDI: 30889483097834); UDI-DI: 10889483083246 (Item # BT2020, Case UDI: 30889483083240); UDI-DI: 10889483083253 (Item # BT2023, Case UDI: 30889483083257); UDI-DI: 10889483086339 (Item # BT2026, Case UDI: 30889483086333); UDI-DI: 10889483091050 (Item # BT2027, Case UDI: 30889483091054); UDI-DI: 10889483076170 (Item # BT2029, Case UDI: 30889483076174); UDI-DI: 10889483077764 (Item # BT2032, Case UDI: 30889483077768); UDI-DI: 10889483080108 (Item # BT2034, Case UDI: 30889483080102); UDI-DI: 10889483080573 (Item # BT2034W, Case UDI: 30889483080577); UDI-DI: 10889483092880 (Item # BT2035, Case UDI: 30889483092884); UDI-DI: 10889483090794 (Item # BT2036, Case UDI: 30889483090798); UDI-DI: 10889483083277 (Item # BT2037, Case UDI: 30889480832771); UDI-DI: 10889483078853 (Item # BT2048, Case UDI: 30889483078857); UDI-DI: 10889483106037 (Item # BT2215, Case UDI: 30889483106031); UDI-DI: 10889483101148 (Item # BT2216, Case UDI: 30889483101142); UDI-DI: 10889483100868 (Item # BT2220, Case UDI: 30889483100862); UDI-DI: 10889483080115 (Item # BT2220-2, Case UDI: 30889483080119); UDI-DI: 10889483088999 (Item # BT2220F, Case UDI: 30889483088993); UDI-DI: 10889483080580 (Item # BT2234, Case UDI: 30889483080584); UDI-DI: 10889483103357 (Item # BT2234FK, Case UDI: 30889483103351); UDI-DI: 10889483090800 (Item # BT2415, Case UDI: 30889483090804); UDI-DI: 10889483086346 (Item # BT2415K, Case UDI: 30889483086340); UDI-DI: 10889483080122 (Item # BT2416, Case UDI: 30889483080126); UDI-DI: 10889483109168 (Item # BT3025, Case UDI: 30889483109162); UDI-DI: 10889483099780 (Item # BT3030, Case UDI: 30889483099784); UDI-DI: 10889483096253 (Item # BT3034, Case UDI: 30889483096257); UDI-DI: 10889483080634 (Item # BT4006-N, Case UDI: 20889483080631); UDI-DI: 10889483091272 (Item # BT4013, Case UDI: 30889483091276); UDI-DI: 10889483160527 (Item # BT4013F, Case UDI: 30889483160521); UDI-DI: 10889483106068 (Item # BT4015, Case UDI: 30889483106062); UDI-DI: 10889483102541 (Item # BT4016, Case UDI: 30889483102545); UDI-DI: 10889483113080 (Item # BT4018, Case UDI: 30889483113084); UDI-DI: 10889483109175 (Item # BT4019, Case UDI: 20889483109172); UDI-DI: 10889483079317 (Item # BT4022, Case UDI: 30889483079311); UDI-DI: 10889483084915 (Item # BT4024, Case UDI: 30889483084919); UDI-DI: 10889483097571 (Item # BT4040, Case UDI: 30889483097575); UDI-DI: 10889483079324 (Item # BT4045, Case UDI: 30889483079328); UDI-DI: 10889483165867 (Item # BT5104P, Case UDI: 30889483165861); UDI-DI: 10889483165843 (Item # BT5107F, Case UDI: 30889483165823). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.
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