[Recalled] ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 — The gowns contain an unknown level of bioburden, unknown microbiological flora,… | FDA 2020-01-11
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 |
|---|---|
| Brand / manufacturer | Cardinal Health |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1024-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 January 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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
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.