FDAMay 30, 2023device
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
What to do
FDA enforcement status: Ongoing
Brands named
deroyal
UPCs
5074975666438200749756664387
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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