[Recalled] Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: Th
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Re |
|---|---|
| Brand / manufacturer | Cardinal Health 200, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2480-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 February 2018 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
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 Cardinal Health 200, LLC
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.