Z-1692-2025 Class II Ongoing

Recalled by Defibtech, LLC — Guilford, CT

Recall Details

Product Type
Devices
Report Date
May 7, 2025
Initiation Date
March 18, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
212 units (OUS only)

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).

Distribution Pattern

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.