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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0556-2009 - External Fixation Device
Model #'s:
ORT99-36501
SYN390.005
SYN390.008
SYN394.84
SYN394.85 and
SYN394.86
Intended for use in the construction of an external fixation frame for treatment of a v...
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2
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01/13/2009
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Sterilmed Inc
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Z-0557-2009 - Femoral Compression Device
Model #'s:
RAD11163
Intended for use in the compression of the femoral artery or vein after cauterization.
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2
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01/13/2009
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Sterilmed Inc
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Z-0558-2009 - Guidewires - Endoscopic (Jag Wires)
Model #'s:
MIC5658 and
MIC630-100
Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic...
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2
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01/13/2009
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Sterilmed Inc
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Z-0559-2009 - Harmonic Scalpel
Model #'s:
ETHACE14S
ETHACE23P
ETHACE36P
ETHCS14C
ETHFCS9
ETHHDH05
ETHLCS-C5 and
ETHLCSC5HA
Intended for use in soft tissue incisions when bleeding control and minimal th...
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2
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01/13/2009
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Sterilmed Inc
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Z-0560-2009 - Lap Instruments/Graspers/Forceps - HOT
Model #'s:
AUT173016
AUT174301
AUT176643
AUT176643
ETH5DCD
ETH5DCS
ETHEBF01
ETHPOUCH
GYR3000PK
GYR3005PK
GYR3640 and
GYR920005PK
Laparoscopic ...
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2
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01/13/2009
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Sterilmed Inc
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Z-0561-2009 - Lap Instruments/Graspers/Forceps - COLD
Model #'s:
AUT173030
AUT174233
AUT174317
AUT176613
AUT176647
AUTECATCH10G and
ETH5DSG
A manual surgical instrument for general use is a nonpowered, h...
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2
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01/13/2009
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Sterilmed Inc
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Z-0562-2009 - Laser Probe Model #': SYN55.26.25
Reprocessed laser probes are part of a laser delivery system and are used in opthalmic procedures where laser energy is the mode of treatment.
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2
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01/13/2009
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Sterilmed Inc
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Z-0563-2009 - Masks - Laryngeal
Model #'s:
AMB321-300-000
AMB321-400-000
AMB321-500-000
LMA12015
LMA12020
LMA12030
LMA12040
LMA12050
LMA12120
LMA12125
LMA12130
LMA12140 and
LMA21140
An oropharyngeal...
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2
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01/13/2009
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Sterilmed Inc
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Z-0564-2009 - Multi-Clip Applier
Model #'s:
APPCA080
AUT134031
AUT134046
AUT134051
AUT134053
AUT176625
AUT176657
AUTPTACK30
ETHEL5ML
ETHER320
ETHMCL20
ETHMCM20
ETHMCM30
ETHMCS20
ETHMSM20 and
WEC5...
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2
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01/13/2009
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Sterilmed Inc
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Z-0565-2009 - Phaco Tips
Model #'s:
ALC30RTS
ALC8065740806
ALC8065740809
ALC8065740837
ALC8065740839
ALC8065750852
ALC8065790020
ALC8065790022 and
ALLOPOR3020L
Intended use of this device is to assist ...
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2
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01/13/2009
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Sterilmed Inc
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