Recall MonitorHealth Products
AirSeal Access Port With Blunt Obturator and AirSeal Access Port With Optical Obturator
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
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
Recall class: Type II
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.