The Recall Desk

FDA (Devices) recall action 63896

California Medical Laboratories Inc recalled 2 products on 2013-01-16

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
2013-01-16
Critical
0
Units
—

Why these products were recalled

California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.

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

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2013-01-16

    California Medical Laboratories Recalls Sterile Rigid Tip Suction Wands

    California Medical Laboratories is recalling sterile rigid tip suction wands because the distal tip may detach and fall into a patient's chest cavity during surgery.

    Product
    Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
    Category
    Distribution
    6 states
  • SevereFDA (Devices)··2013-01-16

    California Medical Laboratories Recalls Rigid Tip Suction Wands Due to Tip Detachment Risk

    California Medical Laboratories is recalling Rigid Tip Suction Wands because the distal tip may detach and fall into a patient's chest cavity during surgery.

    Product
    Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
    Category
    Distribution
    6 states