CanadaAesculap Inc. surgical instrument sets sold in Canada are affected, identifiable by Aesculap branding and the listed model/catalogue numbers (for example MF111R, MD025, RANDOLPH CYCLODIALYSIS CANNULA 19G and others). They were recalled because the devices were distributed into Canada without a Health Canada medical device licence; contact the manufacturer for additional information.
What's being recalled
Companies: Aesculap Inc., 3773 Corporate Parkway, Center Valley, Pennsylvania, United States, 18034.
How to identify it
Affected products: ATR.SUCT 10FR 90UP; Lot or serial number: Not applicable.; Model or catalogue number: MF111R
Affected products: GOULIAN SKIN GRAFT KNIFE SET 1 HNDL5BLD; Lot or serial number: Not applicable.; Model or catalogue number: MD025
Affected products: Lacrimal Cannula; Lot or serial number: Not applicable.; Model or catalogue number: RANDOLPH CYCLODIALYSIS CANNULA 19G
Affected products: Lacrimal Cannula; Lot or serial number: Not applicable.; Model or catalogue number: BISHOP-HARMON CANNULA ANG 19G 24MM
Affected products: Aes House Needle; Lot or serial number: Not applicable.; Model or catalogue number: HOUSE NEEDLE CVD SEMI-S 165MM
Affected products: Aes House Needle; Lot or serial number: Not applicable.; Model or catalogue number: HOUSE NEEDLE CVD SEMI-S ROSEN-PT 165MM
Affected products: Atr.Suction; Lot or serial number: Not applicable.; Model or catalogue number: ATR.SUCT 7FR 90UP 215MM
Affected products: Atr.Suction; Lot or serial number: Not applicable.; Model or catalogue number: ATR.SUCT 7FR 90DN 215MM
Affected products: ELAN/MICROTRON IRRIG-TUBINGDIS; Lot or serial number: Not applicable.; Model or catalogue number: US431
Affected products: Nazal Knife; Lot or serial number: Not applicable.; Model or catalogue number: MCCABE KNIFE DISSEC BLDANG 20&40 185MM
Affected products: Nazal Knife; Lot or serial number: Not applicable.; Model or catalogue number: FREER SEPTUM KNIFE 5X8MM 155MM
Affected products: Nazal Knife; Lot or serial number: Not applicable.; Model or catalogue number: HOUSE INCUDOSTAPEDIAL KNIFE ANG 168MM
Affected products: Air Injection Cannula; Lot or serial number: Not applicable.; Model or catalogue number: AIR INJECTION CANNULA 27 GAUGE 19MM
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: FRAZIER LONG-SUCT 12FR 165MMWRK-LGTH
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: FRAZIER LONG-SUCT 8FR 165MM WRK-LGTH
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: YANKAUER SUCTION TUBE CVD 350MM
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: FRAZIER LONG-SUCT 11FR 165MM WRK-LGTH
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: HOUSE SUCTION TUBE STR 20GA 105MM
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: CLEANING WIRE F/BARON SUCTION TUBES
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: ANDREWS PYNCHON SUCTION TUBE 225MM
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: FRAZIER LONG-SUCT 10FR 165MM WRK-LGTH
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: STYLET F/MD129R 12FR
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: STYLET, FOR SUCTION CANNULA MD125R, 8 FR
Affected products: Frazier Long-Suct; Lot or serial number: Not applicable.; Model or catalogue number: TIP FOR ANDREWS PYNCHON SUCTION
Affected products: ATR.SUCT 10FR 90DN; Lot or serial number: Not applicable.; Model or catalogue number: MF108R
Affected products: ROSEN Knife-Curette Ang-45deg 2mm 158mm; Lot or serial number: Not applicable.; Model or catalogue number: MA292R
Affected products: Dual Reusable Bipolar Cord; Lot or serial number: Not applicable.; Model or catalogue number: US359
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOFCP,230X125X1.5MM,INS,IRRG
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: REVERSE ACTION FCPS INSUL 1.0MM 254MM
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOLAR FCPS STR 150/50/1.0MM
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOLAR FCPS STR 190/90/2.0MM
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOFCP,215X115X1.0MM,INS,IRRG
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOLAR FCPS STR 255/150/0.7MM
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOFCP,195X75X1.5MM,INS,IRRG
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOFCP,195X75X1.5MM,INS,NONIRR
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOLAR FCPS STR 150/50/0.5MM
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOLAR FCPS STR 215/115/0.5MM
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOLAR FCPS STR 215/115/1.0MM
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOFCP,190X90X2.0MM,INS,IRRG
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOFCP,254X146X0.7MM,INS,IRRG
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOFCP,215X115X0.5MM,INS,IRRG
Affected products: Goldtip BIPOFCP; Lot or serial number: Not applicable.; Model or catalogue number: GOLDTIP BIPOLAR FCPS STR 230/125/1.5MM
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)