[Recalled] Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens — Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens |
|---|---|
| Brand / manufacturer | Vygon Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1807-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 May 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
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 Vygon 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.
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