Z-0369-2024 Class II Ongoing
FDA device recall Z-0369-2024 was initiated by SunMed Holdings, LLC on October 11, 2023 and is designated Class II. Reason for recall: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- October 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
Reason for Recall
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Distribution Pattern
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: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 # CPRM2216FPMC); UDI-DI:10888277632349, (Case UDI: 20888277632346, ITEM # CPRM2216M); UDI-DI:10193489009750, (Case UDI: 20193489009757, ITEM # CPRM2216P3M3); UDI-DI:10888277669833, (Case UDI: 20888277669830, ITEM # CPRM2216PCM); UDI-DI:10888277629684, (Case UDI: 20888277629681, ITEM # CPRM2216PM); UDI-DI:10193489016000, (Case UDI: 40884389121260, ITEM # CPRM2216PM6); UDI-DI:10888277655157, (Case UDI: 20888277655154, ITEM # CPRM2226FM); UDI-DI:10888277659766, (Case UDI: 20888277659763, ITEM # CPRM2226FM3); UDI-DI:10884389811337, (Case UDI: 20884389811334, ITEM # CPRM2226FPM); UDI-DI:10193489001952, (Case UDI: 20193489001959, ITEM # CPRM2226FPWM); UDI-DI:10888277632356, (Case UDI: 20888277632353, ITEM # CPRM2226M); UDI-DI:10888277656130, (Case UDI: 20888277656137, ITEM # CPRM3312FM); UDI-DI:10888277698871, (Case UDI: 20888277698878, ITEM # CPRM3312FM123); UDI-DI:10888277654822, (Case UDI: 20888277654829, ITEM # CPRM3312FPM); UDI-DI:10193489001167, (Case UDI: 20193489001164, ITEM # CPRM3312FPM3); UDI-DI:10193489181944, (Case UDI: 20193489181941, ITEM # CPRM3312FPMC); UDI-DI:10888277632363, (Case UDI: 20888277632360, ITEM # CPRM3312M); UDI-DI:10888277698888, (Case UDI: 40888277362605, ITEM # CPRM3312M3); UDI-DI:10193489009767, (Case UDI: 20193489009764, ITEM # CPRM3312P3M3); UDI-DI:10888277718652, (Case UDI: 20888277718569, ITEM # CPRM3312PM); UDI-DI:10884389975893, (Case UDI: 20884389975890, ITEM # CPRM3312PM2); UDI-DI:10888277675193, (Case UDI: 20888277675190, ITEM # CPRM3312PMC2); UDI-DI:10888277674028, (Case UDI: 20888277674025, ITEM # CPRM3312PMTD1); UDI-DI:10884389975909, (Case UDI: 20884389975906, ITEM # CPRM3312PMX); UDI-DI:10888277667815 (Case UDI: 20888277667812, ITEM # CPRM3312PWM); UDI-DI:10080196659777, (Case UDI: 20080196659774, ITEM # CPRM3322FM); UDI-DI:10888277632370, (Case UDI: 20888277632377, ITEM # CPRM3322M); UDI-DI:10888277718562, (Case UDI: 20888277718569, ITEM # CPRM3322PM); UDI-DI:10193489181951, (Case UDI: 20193489181958, ITEM # CPRM4416FPMC); UDI-DI:10888277700499, (Case UDI: 20888277700496, ITEM # CPRM4416M); UDI-DI:10888277700512, (Case UDI: 20888277700519, ITEM # CPRM4426M). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.