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Ventlab, LLC BreathTech manual resuscitators with… recallZ-0362-2024 · SunMed Holdings, LLC · initiated Oct 11, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from SunMed Holdings, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0362-2024
Status
Open, Classified
Initiated by the company
Oct 11, 2023
Posted by the FDA
Nov 21, 2023
Recalling firm
SunMed Holdings, LLC
Product code
BTM
FDA submissions
K012842
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.

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.

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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.

Devices named in this recall

36 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93237).

Sources and updates

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