Recall Z-0362-2024 · BTM Ventilator, Emergency, Manual (Resuscitator)
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,
| Date | Nov 21, 2023 (initiated Oct 11, 2023) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012842 | V*CARE MANUAL RESUSCITATOR Ventlab Corp., Sep 18, 2001 |