Reported May 7, 2025 · Ongoing
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language),…
Defibtech, 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: Defibtech, LLC · 741 Boston Post Rd Ste 201 · Guilford, CT · 06437-2714
Is this the product you have?
- Automated External Defibrillators, Model DDU-2300
- Item numbersDCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
- Lot codes and dates
- UDI-DIs00815098020232 (DDU-2300, export version), 10815098020239 (DDU-2300, export version (configuration level))
- Lot numbers
212 of 212 codes
400174411400174755400175965400179100400179205400179279400179223400179206400179271400191481400191516400197352400191375400164982400155836400159075400139521400168419400160156400165319400190176400187549400187582400190198400186761400187569400150859400150811400187620400150948400182206400152805400200222400173689400173695400170424400182464400191479400179417400179733400168929400179607400179275400191478400151695400151696400151699400151718400151724400151727400151728400151730400151756400151799400151802400151812400151841400151843400151844400151858
- Amount recalled
- 212 units (OUS only)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
This product could cause temporary or reversible health problems — stop using it.
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