[Recalled] Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. — The heated tube sets were consistently leaking and detaching from the cassette | FDA 2019-03-07
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. |
|---|---|
| Brand / manufacturer | Stryker Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1726-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 07 March 2019 |
| EAN / barcode | 07613327055634 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The heated tube sets were consistently leaking and detaching from the cassette.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Stryker Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.