Medline manual resuscitators with integrated manometer recall
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.
Why was Medline manual resuscitators with integrated manometer recalled?
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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.
- Recalling firm
- SunMed Holdings, LLC
- Quantity
- N/A
- 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.
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)