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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-0555-2009 - EP Catheter
Model #'s:
BIOD6-DR-005-RT
BIOD6-DR-010-RT
DAI401381
DAI401449
DAI401904
DAI401915 and
EPT7003D
Intended for temporary use during electrophysiology studies for intracardiac sen...
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2
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01/13/2009
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Sterilmed Inc
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Z-0554-2009 - EP Cables
Model #'s:
BAR560004P
BIOC10MR10MSTKS
BIOC5-MH/NAVMH-S
CORC6-MR10/EPTR-S
DAI401972
DAI401976
DAI401977
DAI401981
DAI401983
EPT5454S
EPT613 and
EPT651
An electrode cable is a ...
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2
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01/13/2009
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Sterilmed Inc
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Z-0548-2009 - Drill Bits
Model #'s:
DEP14043
MIC8053-019
RIC21-0438
RIC21-0439
RIC21-0441
RIC21-0442
RIC71173504
RIC71173505
RIC71631117
SMI21-0445
STR5800-4-125
STR60-13570
SYN03.010.060
SYN03.010....
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2
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01/13/2009
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Sterilmed Inc
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Z-0553-2009 - Compression Sleeves
Model #'s:
HUNDVT10-1 and
KEN5329
The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that ...
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2
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01/13/2009
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Sterilmed Inc
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Z-0552-2009 - Colorado Electrodes
Model #'s:
COLN104A
COLN112A and
STRN103A
Intended for precision cutting or dissecting and cauterizing soft tissue.
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2
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01/13/2009
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Sterilmed Inc
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Z-0551-2009 - Cardiac Imaging Catheter
Model #'s:
ACU08267996 and
ACU55790
Intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great...
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2
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01/13/2009
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Sterilmed Inc
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Z-0550-2009 - Burrs
Model #'s:
ANSL-3SB
ANSL-5D
ANSQD11-4OVDC
HAL5056-118
HAL5056-166
HAL5091-106
HAL5091-112
HAL5091-122
HAL5091-125
HAL5091-136
HAL5091-144
HAL5091-164
HAL5092-120
HAL5092-168
HA...
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2
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01/13/2009
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Sterilmed Inc
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Z-0549-2009 - Biopsy Forceps, Hot
Model #'s:
BAL60110
BAR000852
BAR000854 and
MIC1550
Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to f...
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2
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01/13/2009
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Sterilmed Inc
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Z-0575-2009 - Biopsy Forceps, Cold
Model #'s:
BAR000386
BAR000388
MIC1012
MIC1331
MIC1333
MIC1337
MIC1536
MIC1589
MIC1597
MIC1598 and
MIC1599
The Reprocessed Cold Biopsy Forceps are intended to be use...
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2
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01/13/2009
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Sterilmed Inc
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