Reported Oct 16, 2013 · Terminated

Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and…

Draeger Medical, 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: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042

Is this the product you have?

Draeger Fabius GS Premium, Fabius OS, Fabius Tiro
Fabius Tiro D-M Product Usageused to administer anesthesia and ventilation to patients during surgical procedures

Lot codes and dates: Part Nos. 8607000 (GS Permium) 8606000 (Fabius OS and Fabius Tiro) 8608400 (Fabius
Tiro D-M)ASEC-0055 with lot numbers
150 of 150 codes
ASEC-0186
ASED-0006
ASED-0074
ASED-0291
ASEC-0056
ASEC-0205
ASED-0007
SED-0075 ASED-0292
ASEC-0061
ASEC-0206
ASED-0020
ASED-0079
ASED-0293
ASEC-0062
ASEC-0207
ASED-0021
ASED-0139
ASED-0294
ASEC-0070
ASEC-0208
ASED-0023
ASED-0160
ASED-0295
ASEC-0071
ASEC-0209
ASED-0024
ASED-0161
ASED-0296
ASEC-0112
ASEC-0210
ASED-0025
ASED-0162
ASEE-0021
ASEC-0124
SEC-0211
ASED-0031
ASED-0163
ASEE-0022
ASEC-0125
ASEC-0212
ASED-0032
ASED-0164
ASEE-0023
ASEC-0126
ASEC-0213
ASED-0033
ASED-0165
ASEE-0041
ASEC-0169
ASEC-0214
ASED-0034
ASED-0166
ASEE-0042
ASEC-0170
ASEC-0236
ASED-0035
ASED-0167
ASEE-0058
ASEC-0171
ASEC-0248
Amount recalled: 1127 units

Where it was sold

Nationwide

Why it was recalled

Stop using this product now

During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.

Using this product could cause serious injury, illness or death — stop using it now.

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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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