The Recall Desk

FDA (Devices) recall action 70430

Bard Access Systems recalled 5 products on 2015-03-25

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
2015-03-25
Critical
0
Units
290,671

Why these products were recalled

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

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.

1–5 of 5

  • ModerateFDA (Devices)··2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Flush Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain device kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in various catheter kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintro
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    0 states
  • HighFDA (Devices)··2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling 16,410 units of BD PosiFlush Saline Flush Syringes included in various device kits because open seals may impact product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, Power
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain catheter kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush t
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G
    Category
    Distribution
    0 states