Recall Z-1410-2020 ยท LRO General Surgery Tray
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
| Date | Feb 19, 2020 (initiated Feb 4, 2020) |
| Status | Terminated |
| Reason | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Root cause | Environmental control |
| Action | DeRoyal issued their recall on 1/26/2020 to the end user level by sending recall letters to its direct accounts. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. |
| Quantity | 2,100 units total |
| Distribution | US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |