Recall Z-0369-2024
SunMed Holdings, LLC · initiated October 11, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resuscitator REF #s: CPRM3312FM, CPRM3312FM123, CPRM3312FPM, CPRM3312FPM3, CPRM3312FPMC, CPRM3312M, CPRM3312M3, CPRM3312P3M3, CPRM3312PM, CPRM3312PM2, CPRM3312PMC2, CPRM3312PMTD1, CPRM3312PMX, CPRM3312PWM, CPRM3322FM, CPRM3322M, CPRM3322PM; 3. Pediatric Resuscitator REF #s: CPRM2216FM, CPRM2216FM3, CPRM2216FPM, CPRM2216FPM3, CPRM2216FPMC, CPRM2216M, CPRM2216P3M3, CPRM2216PCM, CPRM2216PM, CPRM2216PM6, CPRM2226FM, CPRM2226FM3, CPRM2226FPM, CPRM2226FPWM, CPRM2226M; 4. Small Adult Resuscitator REF #s: CPRM4416FPMC, CPRM4416M, CPRM4426M.
Codes / lots: UDI-DI:10888277628298, (Case UDI: 20888277698885, ITEM # CPRM1116FM); UDI-DI:10888277667785, (Case UDI: 20888277667782, ITEM # CPRM1116FMT); UDI-DI:10888277654815, (Case UDI: 20888277654812, ITEM # CPRM1116FPM); UDI-DI:10193489082685, (Case UDI: 20193489021544, ITEM # CPRM1116FPM4); UDI-DI:10888277628304, (Case UDI: 20888277628301, ITEM # CPRM1116M); UDI-DI:10888277698826, (Case UDI: 20888277698823, ITEM # CPRM1116MC); UDI-DI:10888277628311, (Case UDI: 20888277628318, ITEM # CPRM1116PM); UDI-DI:10888277674004, (Case UDI: 20888277674001, ITEM # CPRM1116PMT); UDI-DI:10888277629677, (Case UDI: 20888277629674, ITEM # CPRM1126FM); UDI-DI:10884389810293, (Case UDI: 20884389810290, ITEM # CPRM1126FPM); UDI-DI:10193489001945, (Case UDI: 20193489001942, ITEM # CPRM1126FPWM); UDI-DI:10888277628328, (Case UDI: 20888277628325, ITEM # CPRM1126M); UDI-DI:10888277655140, (Case UDI: 20888277655147, ITEM # CPRM2216FM); UDI-DI:10888277698857, (Case UDI: 20888277717678, ITEM # CPRM2216FM3); UDI-DI:10888277632332, (Case UDI: 20888277632339, ITEM # CPRM2216FPM); UDI-DI:10193489001150, (Case UDI: 20193489001157, ITEM # CPRM2216FPM3); UDI-DI:10193489181937, (Case UDI: 20193489181934, ITEM #…
Reason for recall
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0369-2024
- Initiated
- October 11, 2023
- Posted by FDA
- November 21, 2023
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- 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.
- Recalling firm
- SunMed Holdings, LLC, Grand Rapids, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0361-2024 Class II | Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | 10/11/2023Open, Classified |
| Z-0362-2024 Class II | Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | 10/11/2023Open, Classified |
| Z-0363-2024 Class II | Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | 10/11/2023Open, Classified |
| Z-0364-2024 Class II | Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | 10/11/2023Open, Classified |
| Z-0365-2024 Class II | Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | 10/11/2023Open, Classified |
| Z-0366-2024 Class II | Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | 10/11/2023Open, Classified |
| Z-0367-2024 Class II | Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | 10/11/2023Open, Classified |
| Z-0368-2024 Class II | Curaplex manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | 10/11/2023Open, Classified |