SunMed Holdings, LLC: 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.

Recall number

Z-0362-2024

Recalling firm

SunMed Holdings, LLC

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.

Status

Open, Classified

Initiated

2023-10-11

Posted

2023-11-21

Terminated

not on file

Reason

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

Root cause

Device Design

Action

Customer notification was emailed October 11, 2023 advising customers that monitoring of tidal carbon dioxide in critically ill patients is recommended because use of accessories (e.g. PEEP valve) on the exhalation port of manual resuscitators may increase backward leak in the integrated manometer due to increased expiratory resistance. This affects all lots with duckbill-style patient valve with integrated manometer manufactured since 09/21/2019. Customers are to disseminate this information to all users and complete and return the response for. The notice also notes manual resuscitator IFUs will be updated to include this information as a warning statement.

Quantity

not on file

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.

Lot, serial or model codes

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.

510(k) numbers

["K012842"]

PMA numbers

not on file

Product code

BTM

Firm FEI

1314417

Firm city

Grand Rapids

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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