The Recall Desk

FDA (Devices) recall action 88213

INNOVATIVE TOMOGRAPHY PRODUCT GMBH recalled 3 products on 2021-08-04

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2021-08-04
Critical
0
Units
—

Why these products were recalled

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

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

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2021-08-04

    Coaxial Interventional Needles recalled for potential sterilization failure

    Coaxial Interventional Needles from INNOVATIVE TOMOGRAPHY PRODUCT GMBH may not be properly sterilized. Multiple lot numbers are affected and should not be used.

    Product
    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 2
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2021-08-04

    Semi-automatic Biopsy Needles Recalled Due to Sterilization Defect

    INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling semi-automatic biopsy needles because labeled sterile units may not have been adequately sterilized. Affected devices distributed in California should not be used.

    Product
    Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2021-08-04

    Coaxial Interventional Needles Recalled for Potential Sterilization Defects

    INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling Coaxial Interventional Needles distributed in California due to potential sterilization defects. Needles labeled as sterile may not have been adequately sterilized, creating infection risks.

    Product
    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G
    Category
    Distribution
    1 state