Aesculap Inc. Surgical Instrument Sets
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
ATR.SUCT 10FR 90UP |
Not applicable. |
MF111R |
GOULIAN SKIN GRAFT KNIFE SET 1 HNDL5BLD |
Not applicable. |
MD025 |
Lacrimal Cannula |
Not applicable. |
RANDOLPH CYCLODIALYSIS CANNULA 19G |
Lacrimal Cannula |
Not applicable. |
BISHOP-HARMON CANNULA ANG 19G 24MM |
Aes House Needle |
Not applicable. |
HOUSE NEEDLE CVD SEMI-S 165MM |
Aes House Needle |
Not applicable. |
HOUSE NEEDLE CVD SEMI-S ROSEN-PT 165MM |
Atr.Suction |
Not applicable. |
ATR.SUCT 7FR 90UP 215MM |
Atr.Suction |
Not applicable. |
ATR.SUCT 7FR 90DN 215MM |
ELAN/MICROTRON IRRIG-TUBINGDIS |
Not applicable. |
US431 |
Nazal Knife |
Not applicable. |
MCCABE KNIFE DISSEC BLDANG 20&40 185MM |
Nazal Knife |
Not applicable. |
FREER SEPTUM KNIFE 5X8MM 155MM |
Nazal Knife |
Not applicable. |
HOUSE INCUDOSTAPEDIAL KNIFE ANG 168MM |
Air Injection Cannula |
Not applicable. |
AIR INJECTION CANNULA 27 GAUGE 19MM |
Frazier Long-Suct |
Not applicable. |
FRAZIER LONG-SUCT 12FR 165MMWRK-LGTH |
Frazier Long-Suct |
Not applicable. |
FRAZIER LONG-SUCT 8FR 165MM WRK-LGTH |
Frazier Long-Suct |
Not applicable. |
YANKAUER SUCTION TUBE CVD 350MM |
Frazier Long-Suct |
Not applicable. |
FRAZIER LONG-SUCT 11FR 165MM WRK-LGTH |
Frazier Long-Suct |
Not applicable. |
HOUSE SUCTION TUBE STR 20GA 105MM |
Frazier Long-Suct |
Not applicable. |
CLEANING WIRE F/BARON SUCTION TUBES |
Frazier Long-Suct |
Not applicable. |
ANDREWS PYNCHON SUCTION TUBE 225MM |
Frazier Long-Suct |
Not applicable. |
FRAZIER LONG-SUCT 10FR 165MM WRK-LGTH |
Frazier Long-Suct |
Not applicable. |
STYLET F/MD129R 12FR |
Frazier Long-Suct |
Not applicable. |
STYLET, FOR SUCTION CANNULA MD125R, 8 FR |
Frazier Long-Suct |
Not applicable. |
TIP FOR ANDREWS PYNCHON SUCTION |
ATR.SUCT 10FR 90DN |
Not applicable. |
MF108R |
ROSEN Knife-Curette Ang-45deg 2mm 158mm |
Not applicable. |
MA292R |
Dual Reusable Bipolar Cord |
Not applicable. |
US359 |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOFCP,230X125X1.5MM,INS,IRRG |
Goldtip BIPOFCP |
Not applicable. |
REVERSE ACTION FCPS INSUL 1.0MM 254MM |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOLAR FCPS STR 150/50/1.0MM |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOLAR FCPS STR 190/90/2.0MM |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOFCP,215X115X1.0MM,INS,IRRG |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOLAR FCPS STR 255/150/0.7MM |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOFCP,195X75X1.5MM,INS,IRRG |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOFCP,195X75X1.5MM,INS,NONIRR |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOLAR FCPS STR 150/50/0.5MM |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOLAR FCPS STR 215/115/0.5MM |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOLAR FCPS STR 215/115/1.0MM |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOFCP,190X90X2.0MM,INS,IRRG |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOFCP,254X146X0.7MM,INS,IRRG |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOFCP,215X115X0.5MM,INS,IRRG |
Goldtip BIPOFCP |
Not applicable. |
GOLDTIP BIPOLAR FCPS STR 230/125/1.5MM |
Issue
AIC has become aware of the sales and distribution of certain medical devices into the Canadian market without a medical device license from Health Canada. Please note that while devices were unlicensed, the patient safety assessment took into consideration a number of factors, including low number of adverse events (if any) in Canada and globally, relationship of these devices to licensed devices (e.g. accessories to licensed devices being sold without an individual license), similarity to other devices licensed in Canada, and medical device licensing status in other jurisdictions, all of which supports that these devices meet applicable requirements for safety and efficacy.
Additional information
Details
Aesculap Inc.
3773 Corporate Parkway, Center Valley, Pennsylvania, United States, 18034
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