The Recall Desk

FDA (Devices) recall action 72378

Civco Medical Instruments Co. Inc. recalled 5 products on 2015-11-25

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2015-11-25
Critical
0
Units
2,624

Why these products were recalled

Sterility of the product cannot be assured.

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

1–5 of 5

  • HighFDA (Devices)··2015-11-25

    Civco Needle Guide Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 508 boxes of Needle Guide Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2015-11-25

    Civco PercuNav Tracking Bracket Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling PercuNav tracking bracket kits because the sterility of the product cannot be assured.

    Product
    CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2015-11-25

    Civco Medical Instruments Recalls Large Gauge Infiniti Plus Needle Guides

    Civco Medical Instruments is recalling 54 boxes of Large Gauge Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2015-11-25

    Civco Infiniti Plus Needle Guide Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 717 boxes of Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2015-11-25

    Civco Biopsy Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 1,139 boxes of Biopsy Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047…
    Category
    Distribution
    1 state