Reported Jun 29, 2022 · Ongoing
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model…
Smiths Medical ASD Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
11 of 11 products
| Model / number | Product as published |
|---|---|
| — | Model: Model 4000-0100-50 |
4000-0101-249 | — |
4000-0101-50 | — |
4000-0101-51 | — |
4000-0101-78 | — |
4000-0105-249 | — |
4000-0105-51 | — |
4000-0105-78 | — |
4000-0106-00 | — |
4000-0106-01 | — |
4000-0106-231 | — |
- Lot codes and dates
- Model 4000-0100-50UDI 061058603532
- Serial Numbers
345 of 345 codes
200038020003422000351200048520020802000501200027520020892000528200038620020862000555200208320005302000495200208420020872000452200209220004892000283200209820003092000315200043420020942000442200042720003342000388200041520002702000364200040120021032000377200057920021012000352200209020004742000456200210220003072000323200036820003372000429200046620002962000294200034020004572000412200033920005432000470200031920003992000539
- Model 4000-0101-249UDI 061058604007
- Serial Numbers2006483
- Model 4000-0101-50UDI 061058604005
- Serial Numbers
147 of 147 codes
200470120020592004692200470020047022004703200470420047062004708200469820047052004699200469720046912004711200205220020402033894202065920091092004712202065820020582018439201230620123072012308201230920123102012311201231220123132012314201231520123162012317201231820123192012320201232120047142004715200471620047172004718200471920047202004721200472220047232004724200472520047262004727200472820047292004730200473120047322004733
- Model 4000-0101-51UDI 061058604081
- Serial Numbers
3,105 of 3,105 codes
200624420190742017326201734220096322015808200810320080642016913202378720136752013728201434320144412013612201440620116972011707201690420169222016942201385020154422007447200768420080572017211200504620168862016936201446420127882006628200684220167582015388200822420083372011358200243920100422009749200976220134592012409201245520124972002162200740920102792021064200497020052472005250200665320068442015489202398620227972010740
- Amount recalled
- 58671 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
Using this product could cause serious injury, illness or death — stop using it now.
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