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OFFICIAL-SOURCE RECALL · AUSTRALIA
StrykeFlow PS and AHTO Tube Sets Recall: Classification Class II Reason for the Action There
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- StrykeFlow PS and AHTO Tube Sets
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The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Classification Class II Reason for the Action There has been an increase in reported complaints describing leaking from the device during use. During use, the device may experience fluid leakage from the handpiece, which may result in fluid accumulating on the floor. For the AHTO tube sets, saline may react with internal copper wiring, resulting in the release of vaporised saline that may resemble smoke. The potential impacts include user inconvenience, short procedural delays, skin, eye or mucosal membrane irritation, contamination of the surgical field, perceptions of burning, and an increased risk of slip and fall incidents. Instructions for Customers/Users Customers are to: 1. Quarantine any
Hazard
Classification Class II Reason for the Action There has been an increase in reported complaints describing leaking from the device during use. During use, the device may experience fluid leakage from the handpiece, which may result in fluid accumulating on the floor. For the AHTO tube sets, saline may react with internal copper wiring, resulting in the release of vaporised saline that may resemble smoke. The potential impacts include user inconvenience, short procedural delays, skin, eye or mucosal membrane irritation, contamination of the surgical field, perceptions of burning, and an increased risk of slip and fall incidents. Instructions for Customers/Users Customers are to: 1. Quarantine any
Official recall notice
StrykeFlow PS and AHTO Tube Sets
Agency: Therapeutic Goods Administration
Official publication date: August 7, 2026
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