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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-0566-2009 - Rasps
Model #'s:
KOMKM5100-37-113
KOMKM-82
STR1675-115
STR5100-37-113 and
STR5100-37-115
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated devic...
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2
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01/13/2009
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Sterilmed Inc
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Z-0567-2009 - Retractors
Model #'s:
ADE3204
BOS820-175
LON3304 and
LON3334-4G
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposa...
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2
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01/13/2009
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Sterilmed Inc
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Z-0568-2009 - RF Arthroscopy Probe
Model #'s:
ARTA1325-01
ARTA1335-01
ARTA1345-01
ARTA1730-01
ARTA2630-01
ARTA3625-01
ARTA4330-01
ARTAS1335-01
ARTAS4630-01
ARTASC1335-01
ARTASC2530-01
ARTASC4250-01
...
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2
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01/13/2009
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Sterilmed Inc
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Z-0569-2009 - Saw Blade
Model #'s:
BIO506112
BIO506113
DEP2555-91-000
DEP5627-11-500
HAL5023-118
HAL5059-32
HAL5071-133
HAL5071-145
HAL5071-163
HAL5071-181
HAL5071-572
HOWHB-NST-6828-7-791
HOWHB-NST-...
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2
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01/13/2009
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Sterilmed Inc
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Z-0570-2009 - Scissor Tips
Model #'s:
AESPO888
AESPO889
ENCES0102
MIC3112
MIC3122
MIC3142
MIC3152
SNO89-5100 and
SNO89-5300
Intended to be used with a resusable hand piece and are designed to use in mi...
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2
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01/13/2009
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Sterilmed Inc
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Z-0571-2009 - Stone Retrieval Basket Model #': BOS390-105
Used to entrap and remove renal stones and calculi via a rig id or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures...
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2
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01/13/2009
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Sterilmed Inc
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Z-0572-2009 - Tourniquet Cuffs
Model #'s:
INSDT-7024-02
INSDT-7218-01
SMI553322
SMI7010-7002
SMI7010-7006
SMI7010-7007
SMI7010-7008
SMI7010-7010
SMI7010-7011
SMI7010-7012
SMI7010-7015
STR5921-018-136
...
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2
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01/13/2009
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Sterilmed Inc
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Z-0573-2009 - TURP Electrodes
Model #'s:
CIRMLE-24-012
CIRMLE-24-015
OLYA22205C
STO27050F
STO27050G and
STO27050NK
Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coag...
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2
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01/13/2009
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Sterilmed Inc
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Z-0574-2009 - Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suite...
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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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