CanadaAirSeal Access Port with Blunt Obturator (models IASB12-100, IASB5-150, IASB12-120) and AirSeal Access Port with Optical Obturator (models IAS12-150LPI, IAS12-100LPI, IAS5-75LP, IAS8-100LP, IAS8-120LP, IAS5-100LP, IAS12-120LPI, IAS5-120LP) are affected; affected units are identified by those model/catalogue numbers and by lot or serial numbers (more than 10 numbers—contact the manufacturer). They were recalled because a prior manufacturing process update may cause erroneous overpressure alerts under certain conditions, potentially leading to loss of pneumoperitoneum and treatment delays; contact the manufacturer for additional information.
What's being recalled
Companies: Conmed Corporation, 525 French Rd., Utica, New York, United States, 13502-5994.
How to identify it
Affected products: AirSeal Access Port With Blunt Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IASB12-100
Affected products: AirSeal Access Port With Blunt Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IASB5-150
Affected products: AirSeal Access Port With Blunt Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IASB12-120
Affected products: AirSeal Access Port With Optical Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IAS12-150LPI
Affected products: AirSeal Access Port With Optical Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IAS12-100LPI
Affected products: AirSeal Access Port With Optical Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IAS5-75LP
Affected products: AirSeal Access Port With Optical Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IAS8-100LP
Affected products: AirSeal Access Port With Optical Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IAS8-120LP
Affected products: AirSeal Access Port With Optical Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IAS5-100LP
Affected products: AirSeal Access Port With Optical Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IAS12-120LPI
Affected products: AirSeal Access Port With Optical Obturator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: IAS5-120LP
The hazard
Complaint review identified a prior manufacturing process update that may cause erroneous overpressure alerts under certain conditions, potentially leading to loss of pneumoperitoneum and treatment delays. Image was added to IFU to reinforce proper device tightening. No injuries or deaths have been reported.
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)
United States