The Recall Desk

FDA (Devices) recall action 68973

ICU Medical, Inc. recalled 3 products on 2014-08-27

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
2014-08-27
Critical
0
Units
1,000

Why these products were recalled

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product 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

1–3 of 3

  • HighFDA (Devices)··2014-08-27

    ICU Medical Recalls Port Access Kits with Potential Sterility Issues

    ICU Medical is recalling Port Access Kits with MicroClave Clear Connectors because some packages may have open seals, potentially compromising sterility.

    Product
    Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-08-27

    ICU Medical Recalls BD PosiFlush Syringes Due to Open Seals

    ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

    Product
    Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-08-27

    ICU Medical Recalls CAP Change Kits Due to Potential Sterility Issues

    ICU Medical is recalling CAP Change Kits with MicroClave Clear because some packages may have open seals, potentially compromising sterility.

    Product
    CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Distribution
    2 states