Airseal® Ifs Access Port With Trocar
- Recalling firm
- Paragon Care Group New Zealand Limited
- Product
- AirSeal® iFS Access Port with Trocar. [Device]. Affected: Catalogue number - iASB5-150, iASB12-120, iASB12-100, iAS8-120LP, iAS8-100LP, iAS5-75LP, iAS5-120LP, iAS5-100LP, iAS12-150LPI, iAS12-120LPI, iAS12-100LPI
- Reason
- The manufacturer has received an increase in reports of overpressure alerts with AirSeal Access Ports, which in some cases have resulted in delay of treatment. During a review of complaint data, the manufacturer identified that a previous manufacturing process update may, under certain conditions, contribute to overpressure alerts. In response, the Instructions for Use (IFU) have been clarified to ensure proper device tightening., In the event of an overpressure condition, AirSeal® is designed to respond automatically via a built-in venting system, which activates when the pressure exceeds...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-06-11
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/cf939f06-deb7-4ed8-b7ab-dd78d6c1aab8