Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English du...
FDA Recall #Z-1692-2025 — Class II — March 18, 2025
Product Description
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-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)
Reason for Recall
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).
Recalling Firm
Defibtech, LLC — Guilford, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
212 units (OUS only)
Distribution
International Only: Switzerland.
Code Information
UDI-DIs: 00815098020232 (DDU-2300, export version), 10815098020239 (DDU-2300, export version (configuration level)). Lot numbers: 400174411, 400174755, 400175965, 400179100, 400179205, 400179279, 400179223, 400179206, 400179271, 400191481, 400191516, 400197352, 400191375, 400164982, 400155836, 400159075, 400139521, 400168419, 400160156, 400165319, 400190176, 400187549, 400187582, 400190198, 400186761, 400187569, 400150859, 400150811, 400187620, 400150948, 400182206, 400152805, 400200222, 400173689, 400173695, 400170424, 400182464, 400191479, 400179417, 400179733, 400168929, 400179607, 400179275, 400191478, 400151695, 400151696, 400151699, 400151718, 400151724, 400151727, 400151728, 400151730, 400151756, 400151799, 400151802, 400151812, 400151841, 400151843, 400151844, 400151858, 400151905, 400151907, 400151915, 400151920, 400156160, 400186774, 400187567, 400187593, 400187596, 400190090, 400190232, 400190280, 400190303, 400190304, 400190305, 400190318, 400190322, 400190324, 400190355, 400151697, 400151723, 400151851, 400151852, 400151916, 400154576, 400154581, 400154589, 400154595, 400154601, 400154645, 400154646, 400154698, 400154755, 400154839, 400157339, 400157485, 400157486, 400157489, 400157490, 400157510, 400157512, 400157514, 400157516, 400157521, 400150824, 400150860, 400150932, 400141200, 400141209, 400141210, 400141239, 400141257, 400141260, 400141266, 400141275, 400148165, 400148173, 400148186, 400148208, 400148213, 400148247, 400148275, 400150548, 400150839, 400150846, 400150847, 400150848, 400150873, 400150888, 400150894, 400150899, 400150903, 400150912, 400150915, 400150916, 400150921, 400150930, 400150933, 400150936, 400150937, 400150958, 400150959, 400150962, 400150965, 400150968, 400150969, 400150979, 400150991, 400156277, 400156418, 400156430, 400156431, 400187368, 400187561, 400187579, 400187601, 400190175, 400150825, 400150892, 400150911, 400150964, 400187539, 400187583, 400190295, 400187697, 400187703, 400187704, 400187708, 400187719, 400187730, 400187747, 400190293, 400190365, 400190366, 400190381, 400190412, 400190415, 400081869, 400081970, 400170423, 400173514, 400154604, 400154608, 400154609, 400154613, 400154666, 400154671, 400154684, 400154798, 400154799, 400154810, 400168739, 400168745, 400168809, 400168926, 400168943, 400168951, 400168997, 400172421, 400173420, 400173433, 400173489, 400173496, 400173509, 400173513, 400173539, 400173540, 400159593, 400159613, 400162216, 400162221, 400162248.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated