AirSeal Access Port With Blunt Obturator and AirSeal Access Port With Optical Obturator
Brand(s)
Last updated
Summary
Product
AirSeal Access Port With Blunt Obturator and AirSeal Access Port With Optical Obturator
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| AirSeal Access Port With Blunt Obturator | More than 10 numbers, contact manufacturer. | IASB12-100 |
| AirSeal Access Port With Blunt Obturator | More than 10 numbers, contact manufacturer. | IASB5-150 |
| AirSeal Access Port With Blunt Obturator | More than 10 numbers, contact manufacturer. | IASB12-120 |
| AirSeal Access Port With Optical Obturator | More than 10 numbers, contact manufacturer. | IAS12-150LPI |
| AirSeal Access Port With Optical Obturator | More than 10 numbers, contact manufacturer. | IAS12-100LPI |
| AirSeal Access Port With Optical Obturator | More than 10 numbers, contact manufacturer. | IAS5-75LP |
| AirSeal Access Port With Optical Obturator | More than 10 numbers, contact manufacturer. | IAS8-100LP |
| AirSeal Access Port With Optical Obturator | More than 10 numbers, contact manufacturer. | IAS8-120LP |
| AirSeal Access Port With Optical Obturator | More than 10 numbers, contact manufacturer. | IAS5-100LP |
| AirSeal Access Port With Optical Obturator | More than 10 numbers, contact manufacturer. | IAS12-120LPI |
| AirSeal Access Port With Optical Obturator | More than 10 numbers, contact manufacturer. | IAS5-120LP |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
| Conmed Corporation |
| 525 French Rd., Utica, New York, United States, 13502-5994 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82267
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