Reported Apr 24, 2024 · Ongoing
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d)…
Smiths Medical ASD Inc.
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: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
10 of 10 products
| # | Product as published |
|---|---|
| 1 | 4000-0101-249 |
| 2 | 4000-0101-50 |
| 3 | 4000-0101-51 |
| 4 | 4000-0105-249 |
| 5 | 4000-0105-50 |
| 6 | 4000-0105-51 |
| 7 | 4000-0105-78 |
| 8 | 4000-0106-00 |
| 9 | 4000-0106-01 |
| 10 | 4000-0106-231 |
- Lot codes and dates
- All serial numbers Medfusion Model 3500 pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a) 4000-0101-249, UDI/DI 10610586040078
- Serial Numbers
2035426b) 4000-0101-50UDI/DI 10610586040054
- Serial Numbers
2033894c) 4000-0101-51UDI/DI 10610586040818
- Serial Numbers
117 of 117 codes
200270620040982006133200638220074112008160200904020090702009661200970920097232009734200999720108372011049201126220120962013299201380520206282020630202063120209722023768202398320239842023985202484420249132024914202504020269212026922202692320269242026925202692620269272026928202692920269302026931202693420269352026936202693720269382026939202694020269412026942202694320269442026945202694620269472026948202694920269502026951
- Serial Numbers
202636520274052035029e) 4000-0105-50UDI/DI none
- Serial Numbers
202291220229132022914f) 4000-0105-51UDI/DI 10610586043567
- Serial Numbers
1,862 of 1,862 codes
201915020192832019287201929420192992019304201930920193692019471201969420197292019761201977720198072019808201988320200962020132202015320201542020211202021820202592020328202034820203552020365202042320204262020496202052820205292020530202053120205322020533202053420205352020536202053720205432020583202059220206262021417202216320228832022885202293020229322022936202293720229402022941202294620229472022948202294920229502022952
- Serial Numbers
20261722026433203284720328812033072203313220352152035443203544820354542035457203545820355012036239203648320364942036626h) 4000-0106-00UDI/DI 15019517070750
- Serial Numbers
202614420266912027396203279420328112032870203288920329522032957203295820329922033005203306520330732033123203359520335962033597203359820350272035028203503020350322035034203503720350382035424203543620354632035464203547820355182035540203563620356692036330203637820364022036478203664120366712036940203708420371802037234203736120374722037477203752320377102037828203798720380162038038i) 4000-0106-01UDI/DI 15019517069624
- Serial Numbers
1,493 of 1,493 codes
202296520261552026242202626420262742026292202629320263142026373202638520264042026421202693220269332027025202709820271632027224202722520272682027331202733220273332027456202745920275122027594202759620276012027624202767420277502028841202910420291332030409203041820304212030435203046420304662030467203049220304932030500203050120305092030514203052220305542030560203056320305732030579203058020305942030599203060120306062030617
- Amount recalled
- 7160 pumps
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
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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