Recall Z-0880-2022 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
| Date | Mar 3, 2022 |
| Status | Terminated |
| Reason | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. |
| Root cause | Process control |
| Action | DeRoyal issued their recall on March 3, 2022 to the end user level by mailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the product and the notice of return form that was provided back to DeRoyal. |
| Quantity | 1360 kits |
| Distribution | US distribution to Florida, New Jersey, and Tennessee |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |