Reported Nov 29, 2023 · Ongoing
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include
SunMed Holdings, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SunMed Holdings, LLC · 2710 Northridge Dr Nw Ste A · Grand Rapids, MI · 49544-9112
Is this the product you have?
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include
4 of 4 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
47 of 47 products
Products covered by this recall Model / number Barcodes Product as published CPRM1116FM1088827762829820888277698885UDI-DI:10888277628298, (Case UDI: 20888277698885, ) CPRM1116FMT1088827766778520888277667782UDI-DI:10888277667785, (Case UDI: 20888277667782, ) CPRM1116FPM1088827765481520888277654812UDI-DI:10888277654815, (Case UDI: 20888277654812, ) CPRM1116FPM41019348908268520193489021544UDI-DI:10193489082685, (Case UDI: 20193489021544, ) CPRM1116M1088827762830420888277628301UDI-DI:10888277628304, (Case UDI: 20888277628301, ) CPRM1116MC1088827769882620888277698823UDI-DI:10888277698826, (Case UDI: 20888277698823, ) CPRM1116PM1088827762831120888277628318UDI-DI:10888277628311, (Case UDI: 20888277628318, ) CPRM1116PMT1088827767400420888277674001UDI-DI:10888277674004, (Case UDI: 20888277674001, ) CPRM1126FM1088827762967720888277629674UDI-DI:10888277629677, (Case UDI: 20888277629674, ) CPRM1126FPM1088438981029320884389810290UDI-DI:10884389810293, (Case UDI: 20884389810290, ) CPRM1126FPWM1019348900194520193489001942UDI-DI:10193489001945, (Case UDI: 20193489001942, ) CPRM1126M1088827762832820888277628325UDI-DI:10888277628328, (Case UDI: 20888277628325, ) CPRM2216FM1088827765514020888277655147UDI-DI:10888277655140, (Case UDI: 20888277655147, ) CPRM2216FM31088827769885720888277717678UDI-DI:10888277698857, (Case UDI: 20888277717678, ) CPRM2216FPM1088827763233220888277632339UDI-DI:10888277632332, (Case UDI: 20888277632339, ) CPRM2216FPM31019348900115020193489001157UDI-DI:10193489001150, (Case UDI: 20193489001157, ) CPRM2216FPMC1019348918193720193489181934UDI-DI:10193489181937, (Case UDI: 20193489181934, ) CPRM2216M1088827763234920888277632346UDI-DI:10888277632349, (Case UDI: 20888277632346, ) CPRM2216P3M31019348900975020193489009757UDI-DI:10193489009750, (Case UDI: 20193489009757, ) CPRM2216PCM1088827766983320888277669830UDI-DI:10888277669833, (Case UDI: 20888277669830, ) - Amount recalled
- N/A
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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