Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory config...
FDA Recall #Z-0362-2024 — Class II — October 11, 2023
Product Description
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.
Reason for Recall
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Recalling Firm
SunMed Holdings, LLC — Grand Rapids, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
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.
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated