FDAMarch 3, 2022device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
What to do
FDA enforcement status: Terminated
Brands named
deroyal
UPCs
00749756632317
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)2026-05-18
- FDADeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement2025-01-31
- FDADeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement2025-01-15
- FDADeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-062024-10-03
- FDADeRoyal C-SECTION TRACEPACK, REF 89-9338-062024-10-03
- FDADeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.062024-10-03
- FDADeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-062024-10-03
- FDAGeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART2024-02-13
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