Reported Jul 30, 2025 · Ongoing
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N,…
Covidien
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: Covidien · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214
Is this the product you have?
- Covidien Nellcor
- Bedside SpO2 Patient Monitoring System
REF: PM100N10005941DLPM100NDL10005941DSPM100N10005941-SGDS1000594110005941J10005941JP10005941JPN
- Lot codes and dates
- REF/UI-DI/Bundle Code/IFU Part Number
157 of 157 codes
PM100N/10884521196728/NELL-HOMECAREBNPULSOKSYMETRPM100NPM100NKITPM100NKITCHDEPM100NKITCHFRPM100NKITDAPM100NKITDE-2PM100NKITESPM100NKITFIPM100NKITFRPM100NKIT-FRPM100NKITITPM100NKIT-NLPM100NKITNOPM100NKITPTPM100NKITSVPM100NKITUKPM100N-10PM100N-2XMAXNPM100N-2XMAXN-CCPM100N-3DYS-CCPM100N-DYSPM100N-HCPM100N-MAXNPM100N-MAXN-CCPM100N-OXIAN-CC/PT00156589 - AR - ArabicPT00156609 - AR - ArabicPT00156588 - BG - BulgarianPT00156610 - BG - BulgarianPT00156586 - CS - CzechPT00156612 - CS - CzechPT00156585 - DA - DanishPT00156613 - DA - DanishPT00156578 - DE - GermanPT00156625 - DE - GermanPT00156577 - EL - GreekPT00156626 - EL - GreekPT00156509 - EN - EnglishPT00156328 - EN - EnglishPT00156563 - ES - SpanishPT00156639 - ES - SpanishPT00156583 - ET - EstonianPT00156615 - ET - EstonianPT00156582 - FI - FinnishPT00156616 - FI - FinnishPT00156581 - FR - FrenchPT00156617 - FR - FrenchPT00156587 - HR - CroatianPT00156611 - HR - CroatianPT00156576 - HU - HungarianPT00156627 - HU - HungarianPT00156575 - IT - ItalianPT00156628 - IT - ItalianPT00156580 - KA - GeorgianPT00156618 - KA - GeorgianPT00156591 - KO - KoreanPT00156642 - KO - KoreanPT00156573 - LT - LithuanianPT00156630 - LT - Lithuanian
- REF/UI-DI/Bundle Code/IFU Part Number
- Amount recalled
- 264,790
Where it was sold
Why it was recalled
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
This product could cause temporary or reversible health problems — stop using it.
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