The Recall Desk

FDA (Devices) recall action 71904

Resource Optimization & Innovation Llc recalled 77 products on 2015-10-14

The FDA (Devices) publishes a recall like this one as 77 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 77 pages.

Products
77
Announced
2015-10-14
Critical
0
Units
38,056

Why these products were recalled

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

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

76–77 of 77

  • SevereFDA (Devices)··2015-10-14

    FDA Recalls Robotic Laparoscopic Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 144 robotic laparoscopic surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2015-10-14

    Resource Optimization & Innovation Recalls Sterile Total Hip Surgical Kits

    Resource Optimization & Innovation LLC is recalling 24 sterile total hip surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical pr
    Category
    Distribution
    3 states