The Recall Desk

FDA (Devices) recall action 72098

DeRoyal Industries Inc recalled 2 products on 2015-11-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-11-18
Critical
0
Units
355

Why these products were recalled

Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2015-11-18

    DeRoyal Surgical Kits Recalled Due to Sterilant Exposure

    DeRoyal Industries is recalling specific lots of sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during the sterilization process.

    Product
    DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2015-11-18

    DeRoyal Recalls Sterile Surgical Kits Due to Sterilant Exposure

    DeRoyal Industries is recalling 355 sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during package sterilization.

    Product
    DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF…
    Category
    Distribution
    7 states