FDADecember 19, 2017device
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthr...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
What to do
FDA enforcement status: Terminated
Brands named
deroyal
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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