The Recall Desk

FDA (Devices) recall action 75065

Integra LifeSciences Corp. recalled 6 products on 2016-10-12

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2016-10-12
Critical
0
Units
53

Why these products were recalled

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

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

1–6 of 6

  • ModerateFDA (Devices)··2016-10-12

    Integra CUSA Dissectron Fingertip Laparoscopic Cannula Recalled for Packaging Seal Defect

    Integra LifeSciences is recalling 9 units of CUSA Dissectron Fingertip Laparoscopic Cannulas due to incomplete sterile packaging seals discovered during final inspection.

    Product
    CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-10-12

    Integra Drainage Accessory Kits Recalled Due to Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling specific lots of Integra Drainage Accessory Kits because a final inspection found an incomplete packaging seal, potentially compromising sterility.

    Product
    Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-10-12

    Integra Straight Ventricular Catheter Recalled for Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling 10 units of Straight Ventricular Catheters due to an incomplete packaging seal discovered during final inspection.

    Product
    Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-10-12

    Integra Ventricular Catheter Accessory Kit Recalled for Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling 14 units of the Ventricular Catheter Accessory Kit due to an incomplete sterile packaging seal discovered during final inspection.

    Product
    Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-10-12

    Integra Lumbar Drainage Set Recalled for Incomplete Packaging Seal

    Integra LifeSciences is recalling 18 units of Integral Lumbar Drainage Sets due to incomplete sterile packaging seals discovered during final inspection.

    Product
    Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-10-12

    Integra Lumbar Drainage Set Recalled Due to Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling specific lots of Lumbar Drainage Sets because final inspection revealed an incomplete packaging seal on the sterile product.

    Product
    Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1)…
    Category
    Distribution
    1 state