[Recalled] DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O, — The firm is recalling two custom surgical kits containing the BARD(TM) Toomey I… | FDA 2016-08-11
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O, |
|---|---|
| Brand / manufacturer | DeRoyal Industries Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2679-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 August 2016 |
| EAN / barcode | 40004006 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
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 DeRoyal Industries Inc
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.